MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR080502J

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

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.All information has been placed on file for use in tracking and trending.A response letter was not requested.

Event Description

The following was reported to gore: on an unknown date, a gore® acuseal vascular graft (acuseal) was implanted as an arteriovenous graft.On (b)(6) 2020, a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn) was additionally implanted to treat occlusion at the venous anastomosis of the acuseal.On june 11, 2020, it was reported that the viabahn was occluded.On the same day, thrombectomy using a balloon catheter was performed to treat the occlusion, and blood flow was recovered.After that, platelet count was decreased, and it was revealed that heparin-induced thrombocytopenia (hit) antibody was positive.Therefore, heparin was discontinued and argatroban was administered.Platelet count was recovering.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #17842998.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Additional manufacturer narrative: b6.- relevant tests/laboratory data, including dates.

Manufacturer Narrative

Corrected data: h6.- method code 1.H6.- results code 1.Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10222109
• MDR Text Key: 197964382
• Report Number: 2017233-2020-00461
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Catalogue Number: JHJR080502J
• Device Lot Number: 17842998
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 75