MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number JHJR060202J

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

As the (devices) where overlapped and it is unknown which device(s) may have contributed to the thrombosis/occlusion/restenosis, an additional ( device ) have been included in this report: both gore® viabahn® endoprosthesis devices were placed in same anatomical location at the same time.Lot number and udi number are unknown.Lot number requested but not made available.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following literature was reviewed."a case of stent-graft implantation for postpancreaticoduodenectomy hemorrhage in a patient with a reconstructed gastric tube" tomohiro komada, md, et al.Radiology case reports.2020 dec; 15(12): 2710¿2713.Published online 2020 oct 22.In patients with a reconstructed gastric tube, the right gastroepiploic artery is a very important feeding artery of the tube, which must be preserved when performing a pancreaticoduodenectomy.A (b)(6) man with a reconstructed gastric tube underwent pancreaticoduodenectomy for distal bile duct carcinoma.On postoperative day 8, he had an arterial hemorrhage from a drain, apparently from a ligation of the anterior superior duodenal artery.He, therefore, underwent stent-graft (6 mm × 2.5 cm, viabahn; w.L.Gore, newark, de) placement in the gastroduodenal artery on postoperative day 16.Angiography after implantation did not delineate the proximal portion of the stent-graft, and the possibility of dissection of the proximal vessel was considered.A 6 mm × 5 cm stent-graft (viabahn) was then placed in front of the first stent-graft in the stent, and further light crimping was performed with a balloon catheter (saber; cordis, cardinal health, dublin, oh).Two days after stent-graft implantation, the stent-grafts were temporarily occluded, and the gastric tube was necrotizing.However, thrombolytic therapy allowed the stent-grafts to reopen and prevented gastric tube necrosis.The ischemic changes in the gastric tube improved on endoscopy 6 days after the thrombectomy (fig.3d).Heparin was changed to antiplatelet medications (aspirin and clopidogrel sulfate), and the patient was discharged 53 days after surgery.The ct at 3 months after stent-graft implantation showed that the stent-grafts were occluded, but the contrast effect of the gastric tube was good.The patient did not have any symptoms.We believe our case of stent-graft implantation in the gastroduodenal artery is the first of this kind to successfully prevent lethal necrosis of the gastric tube.

Manufacturer Narrative

Updated attachments.Attached reviewed literature article, "a case of stent-graft implantation for postpancreaticoduodenectomy hemorrhage in a patient with a reconstructed gastric tube" (b)(6), md, et al.Radiology case reports.2020 dec; 15(12): 2710¿2713.Published online 2020 oct 22.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12447780
• MDR Text Key: 280692785
• Report Number: 2017233-2021-02345
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR060202J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male