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

Catalog Number PAC091502

Device Problems Kinked (1339); Sticking (1597); Use of Device Problem (1670); Failure to Advance (2524)

Patient Problems Intimal Dissection (1333); Injury (2348); Blood Loss (2597)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).

Event Description

The patient presented with an aneurysm within the right popliteal artery which was intended to be treated with a gore® viabahn® endoprosthesis.It was reported to gore that the medical device was inserted through a 9fr introducer sheath through the common femoral artery and advanced over a stiff guidewire from terumo.It was stated that difficulties were experienced when the gore® viabahn® endoprosthesis reached the adductor canal (hunter¿s canal) due to tortuosity of the patient¿s artery.It was stated that the gore® viabahn® endoprosthesis was tried to be withdrawn through the introducer sheath in order to exchange the guidewire.As resistance was experienced when the medical devices was tried to be inserted into the introducer sheath, further inspection indicated a device expansion at the proximal end mostly resulted from the attempted of device removal through the sheath.As medical device withdrawal was continued, where strong force was required, the common femoral artery was injured.It was reported that, due to the vessel injury/rupture, the patient lost 1 liter of blood.The patient was implanted with another stent (manufacturer unknown) to reconstruct the injured artery.It was stated that the patient did not receive a blood transfusion until today.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 7485981
• MDR Text Key: 107314817
• Report Number: 2017233-2018-00254
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Catalogue Number: PAC091502
• Device Lot Number: 17196140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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