GORE VIABAHN ENDOPROSTHESIS - 3
Report
- Report Number
- 2017233-2020-00304
- Event Type
- Death
- Date Received
- May 4, 2020
- Date of Event
- September 3, 2013
- Report Date
- July 29, 2020
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- PFV
- PMA / PMN Number
- P040037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTED DATA: H6 - CONCLUSIONS CODE 1. ADDITIONAL MANUFACTURER NARRATIVE: NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON PUBLICATION DATE OF THE ARTICLE. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.
CORRECTED DATA: H1. TYPE OF REPORTABLE EVENT. ADDITIONAL MANUFACTURER NARRATIVE: 2 PATIENTS DIED AFTER EMERGENT ER WITH THOSE DEATHS BEING ATTRIBUTED TO ACUTE ON CHRONIC RENAL FAILURE (ACRF) AND MYOCARDIAL INFARCTION (MI). THE SEQUELAE OF ACRF, HYPERKALEMIA, UREMIA AND VOLUME OVERLOAD CAN BE LIFE THREATENING IF NOT ADDRESSED AND UNLIKELY RELATED TO DEVICE PERFORMANCE. AN MI INVOLVES ACUTE MYOCARDIAL ISCHEMIA RESULTING IN AN ACUTE MYOCARDIAL INJURY AND AGAIN UNLIKELY RELATED TO DEVICE PERFORMANCE. ALSO, THE AUTHORS ONLY SHARE THAT THE DEATHS OCCURRED IN THE FIRST 30 DAYS POST OP NOT SPECIFICALLY INTRAOPERATIVELY. MEDWATCH WAS SENT IN ERROR. ADDITIONAL RECEIVED INFORMATION DETERMINED THAT THIS EVENT IS NOT REPORTABLE TO THE FDA AND THEREFORE THE MEDWATCH (AND SUPPLEMENTALS) WILL BE RETRACTED.
ADDITIONAL MANUFACTURING NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #UNK. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.
ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION IS ONGOING. #2017233-2020-00300: FOR THE TYPE I ENDOLEAK INVESTIGATION. #2017233-2020-00301: FOR THE INFOLDING INVESTIGATION. #2017233-2020-00302: FOR THE AMPUTATION AND EARLY DEATH INVESTIGATION. #2017233-2020-00303: FOR THE EARLY AMPUTATION INVESTIGATION.
THE FOLLOWING ARTICLE WAS REVIEWED: 'OUTCOMES OF ENDOVASCULAR AND CONTEMPORARY OPEN SURGICAL REPAIRS OF POPLITEAL ARTERY ANEURYSM'; YING HUANG, M.D., PHD; PETER GLOVICZKI, M.D.; GUSTAVO S. ODERICH, M.D.; AUDRA A. DUNCAN, M.D.; MANJU KALRA, MBBS; MARK FLEMING, M.D.; WILLIAM S. HARMSEN, MS; AND THOMAS C. BOWER, M.D.; DIVISION OF VASCULAR AND ENDOVASCULAR SURGERY AND DEPARTMENT OF HEALTH SCIENCE RESEARCH, MAYO CLINIC; COPYRIGHT 2014 BY THE SOCIETY FOR VASCULAR SURGERY; HTTP://DX.DOI.ORG/10.1016/J.JVS.2014.03.257; PRESENTED AT THE THIRTY-SEVENTH ANNUAL MEETING OF THE MIDWESTERN VASCULAR SURGICAL SOCIETY, CHICAGO, ILL, SEPTEMBER 6-8, 2013. THE PURPOSE OF THIS STUDY WAS TO COMPARE OUTCOMES AFTER ENDOVASCULAR REPAIR AND CONTEMPORARY OPEN REPAIR OF POPLITEAL ARTERY ANEURYSMS. CLINICAL DATA OF POPLITEAL ARTERY ANEURYSM PATIENTS TREATED BETWEEN 2005 AND 2012 WAS REVIEWED. THE GORE® VIABAHN® ENDOPROSTHESIS WAS THE DEVICE USED FOR ENDOVASCULAR REPAIR. THE ARTICLE REPORTED ON PAGE 634 THAT TWO PATIENTS WITHIN 30 DAYS OF IMPLANT DIED AFTER EMERGENT ENDOVASCULAR REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484496 | GORE VIABAHN ENDOPROSTHESIS - 3 | NIP | PFV | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death |