MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for GORE VIABAHN? ENDOPROSTHESIS - 3 JHJR050502J manufactured by W.l. Gore & Associates.
[187926671]
Additional manufacturer narrative: reference medwatch report #2017233-2019-01232 for the death event. Review of the manufacturing records indicated the device met pre-release specifications. The device(s) was not returned. Consequently, direct product analysis was not possible. Additional information about this event could not be obtained. As a result, no conclusion can be drawn. All information has been placed on file for use in tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
[187926672]
The following publication was reviewed: 'a case of viabahn implantation for pseudoaneurysm after pancreatoduodenectomy'. The patient was a (b)(6) years old male. On (b)(6) 2018, pylorus-preserving pancreatoduodenectomy was performed for distal bile duct cancer. Post-operative day (pod) 6 ((b)(6) 2018), pancreatic fistula was confirmed. Pod 8 ((b)(6) 2018), sentinel bleeding was observed from the drain at the anastomosis, however, computed tomography (ct) did not reveal an apparent bleeding point. On pod 9 ((b)(6) 2018), excessive bleeding from the drain was observed, and emergency angiography was performed. Pseudoaneurysm of the common hepatic artery was confirmed, and it was concluded that the bleeding occurred from the pseudoaneurysm. A 6mm x 5cm gore? Viabahn? Endoprosthesis with heparin bioactive surface was implanted to treat the pseudoaneurysm and hemostasis was achieved. On pod 12 ((b)(6) 2018), bleeding from the drain was observed again. Emergency angiography revealed a pseudoaneurysm of the right hepatic artery with extravasation. A 5mm x 5cm gore? Viabahn? Endoprosthesis with heparin bioactive surface was implanted, and hemostasis was achieved. The 5x5 endoprosthesis was occluded right away. No treatment was performed for the occlusion as the purpose of the procedure was hemostasis and it was achieved. After that, biliary fistula was observed and intraperitoneal abscess was formed, so percutaneous drainage was performed. Drainage was continued for the refractory pancreatic fistula and biliary fistula. Pod 85 ((b)(6) 2019), ct was performed as inflammatory response was not ameliorated though drainage was continued. Air was observed inside the occluded endoprosthesis in the right hepatic artery, and diagnosis of stent graft infection was made. No specific treatment was performed for the device infection as the patient's general condition was poor and control of the general condition was the priority. Reportedly, no detail examination for infection was conducted. Infection control was continued; however, the patient expired due to septic shock on (b)(6) 2019. Autopsy was not performed. It was reported the physician does not consider that the viabahn device caused the infection as the patient was post-pancreatoduodenectomy. The patient had poor physical condition just after the pancreatoduodenecotmy and this condition also contributed to the patient's outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00090 |
| MDR Report Key | 9700995 |
| Date Received | 2020-02-12 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-10-06 |
| Device Manufacturer Date | 2017-06-22 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABAHN? ENDOPROSTHESIS - 3 |
| Generic Name | NIP |
| Product Code | PFV |
| Date Received | 2020-02-12 |
| Catalog Number | JHJR050502J |
| Lot Number | 17259364 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |