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

Catalog Number PAJR052502E

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Additional stents were required to achieve optimal outcome.Intra-procedural imaging series were requested from the physician but they were not disclosed to gore for patient data protection reasons.The actual device remains implanted in the and is not available for investigation.The delivery system of the device was discarded at the facility and is not available for investigation.A review of the manufacturing records indicated the lots met pre-release specifications.

Event Description

It was reported that it was planned to treat stenosis of the right superficial femoral artery with a gore® viabahn® endoprosthesis with propaten bioactive surface.Access was gained from the left groin.A 6fr introducer sheath and an advantage guidewire (terumo) were used.Reportedly the right superficial femoral artery was previously treated with an unknown (non-gore) type of a bare metal stent (bms).After dilatation of the lesion the physician advanced the gore® viabahn® endoprosthesis through the bms and deployed the gore® viabahn® endoprosthesis completely at the intended location overlapping the previously implanted bms.It was stated, that when the physician started to withdraw the delivery catheter he felt resistance.To solve the issue, the physician decided to withdraw the expanded endoprosthesis together with the delivery catheter.Reportedly, the gore® viabahn® endoprosthesis was pulled along to the left common iliac artery, where it would no longer move, at which point the endoprosthesis released from the delivery catheter.It was reported that after the physician withdrew the delivery catheter from the patient, he found a part of the deployment line stuck to the delivery catheter, indicating that the deployment line has broken.At this point the gore® viabahn® endoprosthesis was located at the iliac bifurcation level ¿ the distal portion of the device was in the left common iliac artery, the proximal portion of the device was reaching into the aortic lumen partially occluding the right common iliac artery.It was reported that, to solve the partial occlusion, the physician changed to a 14 fr introducer sheath in order to dilate the left common iliac artery and to capture and withdraw the gore® viabahn® endoprosthesis through the sheath, however this was not possible.It was reported, that then the physician decided to perform a "kissing stent" technique using two omnilink elite stent systems (9 mm x 39 mm, abbott) to secure the gore® viabahn® endoprosthesis against the aorto-iliac artery walls.After placing these stents it was realized, that the distal portion of the gore® viabahn® endoprosthesis was not covered and it was occluding the left common iliac artery.Therefore an additional stent (sinus-repo-visual 6f, 9 mm x 60 mm, optimed) was implanted distal to the omnilink elite stent system to secure the distal end of the gore® viabahn® endoprosthesis against the left common iliac artery wall.Another device was used to treat the lesion in the right superficial femoral artery.It was stated, that the incident increased the time of the procedure and thus the anesthesia, and that the risk of infection increased because an additional device was required.Reportedly, up to date, the incident had no known effects on the patient.

Manufacturer Narrative

H6-code 213: 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 broken deployment line.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 loader 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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9989624
• MDR Text Key: 197657863
• Report Number: 2017233-2020-00267
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Catalogue Number: PAJR052502E
• Device Lot Number: 21487280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR