Safety Alert for (1) ANEURX STENT GRAFT SYSTEM AND (2) ANCURE ENDOGRAFT SYSTEM

Safety alert

81

2001-05-11

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The fda has received numerous reports of serious problems that have occurred with grefe endovascular protetic systems. on march 16, 2001, guidant voluntarily suspended the production of the ancure endograft system and removed the affected product. guidant notified the fda that it did not report many malfunction of the device and adverse incidents, including the several serious vascular associates associated with the distribution of the device. guidant also reported that changes in manufacturing were not correctly reported to fda. guidant reports the fda that an internal exam revealed problems with its compliance manipulation system, manufacturing quality systems, documentation procedures and training. the fda has received approximately 25 reports of aneurysmal ruptures as well as other serious adverse events in patients who have undergone the implantation of the stent aneurx's grefe systems. the fda indicates that some factors that were associated with adverse incidents include aneurism ruptures; stent sub-gentle placement greek; endoleak (integrated proximal sealing, retrograded colaseral vascular flow, persistent flow around the grefe); the migration of the body of the device as well as of accessories, possibly associated with the continuation of aortic dilatation; problems with the integrity of the device caused by fractures of metal structure, sutura ruptures, or by tissue traits and aneurysm anatomy. fda issued a date of public health notification letter from april 27, 2001, which is available on the fda's internet address: http://www.Fda.Gov/cdrh/safety/aaa.Html.

The FDA RECOMMENDS THE FOLLOWING: (1) CAREFULLY FOLLOW THE MOST RECENT WARNINGS OF THE DEVICE MANUFACTURER, PRECAUTIONS AND INSTRUCTIONS REGARDING PATIENT SELECTION AND USE OF THE DEVICE; (2) ENSURE THAT ALL PATIENTS WITH AFFECTED IMPLANT DEVICES ARE METICALLY FOLLOWED AND SUBMITTED TO IMAGE MONITORING EXAMS; (3) REPORT PROBLEMS YOU HAVE FOUND WITH THE USE OF THIS DEVICE, AS WELL AS ADVERSE INCIDENTS INVOLVING THIS DEVICE, THE MANUFACTURER AND THE ANVISA. TO REPORT PROBLEM OR ADVERSE ADVERSES ABOUT THE ANCURE SYSTEM TO THE MANUFACTURER, CONTACT THE GUIDANT ON PHONE 0021-1 (650) 470-6200. . TO REPORT PROBLEMS OR ADVERSE ADVERSES ABOUT THE ANEURX SYSTEM TO THE MANUFACTURER, CONTACT YOUR LOCAL MEDTRONIC REPRESENTATIVE. GUIDANT AFFIRMS THAT PATIENTS WHO HAVE RECEIVED ANCURE ENDOGRAFT IMPLANTS UNTIL THIS DATE ARE NOT AFFECTED BY THIS ACTION, AND GUIDANT DOES NOT RECOMMEND THAT DOCTORS TAKE NEAR ACTION ON THESE DEVICES, OTHER THAN CONTINUING NORMAL MONITORING. ECRI RECOMMENDS YOU TO VERIFY AND DETERMINE WHETHER ANY ANEURX SYSTEM WAS IMPLEMENTED IN YOUR INSTITUTION AND BY WHOM. REPORT IMPLANTING THAT THE PRODUCT IS BEING SUBJECT TO REMOVAL. THE IMPLANTATION DOCTOR MUST BE DECIDED IF MEDICAL INTERVENTION IS REQUIRED IN PATIENTS WHO SUBMITTED TO THE IMPLANT. TO REPORT PROBLEMS OR ADVERSE ADVERSES TO ANVISA, CONTACT BY E-MAIL TECNOVIGILANCIA@ANVISA.GOV.BR, BY FAX 0XX61-448-1257 OR BY MAIL TO ADDRESS: TECNOVIGILÁNCIA / ANVISA, SEPN, W3 NORTE, Q515, BL.AB , 4O. ANDAR, SALA 01, BRASÍLIA DF CEP70770-502. THE FDA NEWS IS AVAILABLE ON THE INTERNET AT THE HTTP://WWW.FDA.GOV/CDRH/SAFETY/AAA.HTML ADDRESS.