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

Catalog Number PAH101502E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

In total three reports were submitted for the notified medical incident with the following lot numbers: lot #18219397; udi # (b)(4); this report, lot #18401042; udi # (b)(4); mfr report #2017233-2018-00630, lot #18410292; udi # (b)(4); mfr report #2017233-2018-00631.

Event Description

The patient presented with a popliteal artery aneurysm (4cm in diameter x 20 cm in length) on the left side which was intended to be treated with two gore® viabahn® endoprostheses.It was reported to gore that the placement of the two gore® viabahn® endoprostheses went uneventfully but that the angiography indicated that the two implanted medical devices did not exclude the entire length of the aneurysm.Therefore the decision was made to implant a third gore® viabahn® endoprosthesis.When the final angiography was performed, after the three gore® viabahn® endoprostheses were successfully implanted, it was noticed that the blood was standing still at the distal end of the implanted devices.Consequently, a percutaneous transluminal angioplasty was performed for the anterior tibial artery, the posterior tibial artery as well as for the peroneal artery.It was stated that the outflow appeared much better but that it was still not real fast.It was mentioned that even prior medical device implantation the blood flow was not really fast.After two days the patient presented with a cold leg where a thrombosis of the implanted gore® viabahn® endoprostheses was diagnosed and consequently treated with a venous bypass.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8012693
• MDR Text Key: 125275839
• Report Number: 2017233-2018-00629
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: PAH101502E
• Device Lot Number: 18219397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR