MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for GORE VIABAHN? ENDOPROSTHESIS - 3 manufactured by W.l. Gore & Associates.
[187915231]
Source: journal of japan surgical association, volume 80, number 11, page 1971-1977 (published in november 2019). As the date of event is unknown the publication date 11/1/2019 will be used. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187915232]
The following publication was reviewed: gore viabahn stent placement for hemostasis of intractable hemorrhage in four cases. Case 1: this patient is an (b)(6) years old male. On an unknown date, subtotal stomach-preserving pancreaticoduodenectomy was performed for duodenum papilla cancer. On the 3rd day after the surgery, a pancreatic fistula was observed. Conservative treatment was performed, details not provided. On the 19th day after the surgery, bleeding from a drain was observed, and the patient? S vital signs were diminishing. Angiography revealed a pseudoaneurysm of the common hepatic artery, and a gore? Viabahn? Endoprosthesis with heparin bioactive surface was implanted in the artery for hemostasis. Bleeding from the drain was stopped, and the patient? S vital signs reportedly improved. Antiplatelet therapy was not administered as the physician was concerned about postoperative bleeding, as this was the first case of the device usage for bleeding in this hospital. The patient was monitored. On the 2nd day after the device implantation, the endoprosthesis was occluded. Blood flow in the distal organ was not impaired as there was collateral circulation. No further bleeding was observed, and the patient was discharged from the hospital 19 days after the device implantation. Please note: there was no complaint in case 2, 3 and 4. In the discussion field, the physician considered that antiplatelet therapy should have been started just after the stent-graft implantation to prevent thrombus formation. Therefore, the other 3 cases received the antiplatelet therapy after the stent-graft implantation and thrombus formation or device occlusion was not observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00084 |
| MDR Report Key | 9694385 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-11-01 |
| Date Added to Maude | 2020-02-11 |
| 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 | MARCOS AYALA |
| 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 | 2020-02-11 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-11 |