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

Catalog Number PAH131002E

Device Problem Activation Failure (3270)

Patient Problem Stenosis (2263)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.There was no device or image returned; therefore, no physical evaluation of the device can be performed.No root cause was found following an engineering evaluation.The process fmea indicates the final device and constraint sleeve may have a potential impact on the alleged partial deployment.However, there was no evidence to support that the final device, deployment line, or constraint sleeve were damaged during assembly.The following information was evaluated in the evaluation of this complaint: dhr lot review for final device and constraint sleeve using the master process sheets for rejects relating to the aforementioned reported event.Machine files for the stent winder, automatic tape and transfer machine, edge trim laser, loader, die bonder, rf bonder, and constraint sleeve braiders from bm-ram near the time of manufacturing of the device and the component were evaluated for non-routine maintenance that could contribute to final device, deployment line, and constraint sleeve damage.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is inconclusive as it relates to the event description.

Event Description

It was reported, that the patient was provided with an arterio-venous fistula in the arm previously.On (b)(6) 2020, the patient was treated for stenosis in the proximal cephalic vein.After percutaneous transluminal angioplasty (pta) with an atlas® pta dilatation catheter (12 mm x 60 mm, bard) the cephalic vein recoiled immediately.Therefore it was decided to treat the lesion with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® endoprosthesis).The viabahn® endoprosthesis was advanced to the lesion through a 14fr gore® dryseal flex introducer sheath over a 0.035¿ guide wire (manufacturer unknown).They started the deployment pulling the deployment line.Reportedly, the viabahn® endoprosthesis deployed and started to expand from hub to tip.They immediately stopped pulling the deployment line and retracted the viabahn® endoprosthesis back through the introducer sheath and from the patient for the following anatomical reasons: the distal diameter of the cephalic vein was 10.5 mm and the proximal diameter was 11.4 mm.So they had concerns that the result might be compromised if the viabahn® endoprosthesis opens from hub to tip.Reportedly, they completed the procedure successfully using another viabahn® endoprosthesis of the same type and size.

Manufacturer Narrative

Multiple attempts have been made from the gore associate to the complainant in order to get additional information.As no further information related to this complaint will be provided by the complainant, this event will be closed with the information received.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10027779
• MDR Text Key: 197655354
• Report Number: 2017233-2020-00331
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2021
• Device Catalogue Number: PAH131002E
• Device Lot Number: 18672093
• 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 Age: 78 YR
• Patient Weight: 89