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

Catalog Number PAH101502E

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was presented with an aneurysm in the right popliteal artery which was intended to be treated with a gore® viabahn® endoprosthesis.An antegrade approach was used where the medical device was inserted through a 12fr introducer sheath and advanced over a 0.035 guidewire to the target lesion.It was reported to gore that when medical device deployment was initiated, some force was experienced while the proximal portion of the endoprosthesis was tried to be deployed.Based on the experienced deployment difficulties a validation of the deployment status of the device verified that the deployment line was broken and that the proximal portion of the endoprosthesis remained constrained on the catheter.It was reported to gore that several attempts were made to expedite the deployment of the endoprosthesis.Firstly the delivery catheter of the endoprosthesis was tried to be moved to force the deployment.This attempt remained unsuccessfully.Secondly a ptca balloon catheter was inserted over a 0.014 guidewire close to the constrained portion of the endoprosthesis to force deployment.Also this attempt remained unsuccessfully.Thirdly it was tried to cannulate the constrained portion without any success.Fourthly the delivery catheter was cut outside of the 12fr introducer sheath and a smaller sheath was inserted with the unsuccessful attempt to remove the partial deployed endoprosthesis from the patient¿s vessel.Finally the partial deployed endoprosthesis was retrieved into the proximal superficial femoral artery by using a snare device where the device was surgically removed.It was stated that the lesion was repaired with a patch.The procedure was successfully completed by implanting two gore® viabahn® endoprostheses.It was stated that the second gore® viabahn® endoprosthesis was needed to be implanted in order to treat a vessel dissection which occurred based on the deployment difficulties of the first used medical device.

Manufacturer Narrative

Engineering evaluation: the device was returned in three separate pieces: the distal shaft with a partially deployed endoprosthesis still mounted, part of the proximal catheter, and the deployment line attached to the deployment knob.It was reported in the additional information that the delivery system was cut and stent wire were damaged due to surgical removal.Approximately 12.7cm of the endoprosthesis was fully expanded.Approximately 8mm of the endoprosthesis was constrained by the inner braided constraining line.The inner braided constraining line was compressed.Approximately 7mm of the endoprosthesis was partially expanded.There were multiple strut rows in the middle of the expanded endoprosthesis that appeared to be detached from the endoprosthesis.The body tape on these strut rows appeared to be displaced.The strut rows at the start of the expanded proximal end of the endoprosthesis appeared to be detached from the endoprosthesis.The body tape on these strut rows appeared to be displaced.The first strut row from the proximal end of the device appeared to be outwardly bent.In the 15mm of the endoprosthesis that was not fully expanded, the nitinol wire was disrupted.There appeared to be 5 single strands of the deployment line at the proximal end of the endoprosthesis attached to the braided constraining line.The single strands had measurements of approximately 25mm, 10mm, 10mm, 4mm, and 3mm.The dual lumen catheter was attached to the transition and a small portion of the distal shaft.The other end of the catheter appeared frayed and torn.The catheter measured to approximately 26.5cm.There were seven pairs of crimping markings on the catheter.There was approximately 212cm of deployment line (including the single fibers) attached to the deployment knob.There were three single fibers at the end of the deployment line and they measured to approximately 60mm, 10mm, and 7mm.There was a single knot in the deployment line approximately 28cm from the deployment knob.Based on the device examination performed, no manufacturing anomalies were identified.Manufacturing plant was corrected.Event description was updated.

Event Description

The patient was presented with an aneurysm in the right popliteal artery which was intended to be treated with a gore® viabahn® endoprosthesis.An antegrade approach was used where the medical device was inserted through a 12fr introducer sheath and advanced over a 0.035 guidewire to the target lesion.It was reported to gore that when medical device deployment was initiated, some resistance was experienced while the proximal portion of the endoprosthesis was tried to be deployed.Based on the experienced deployment difficulties a validation of the deployment status of the device verified that the deployment line was broken and that the proximal portion of the endoprosthesis remained constrained on the catheter.It was reported to gore that several attempts were made to expedite the deployment of the endoprosthesis.Firstly the delivery catheter of the endoprosthesis was tried to be moved to force the deployment.This attempt remained unsuccessfully.Secondly a ptca balloon catheter was inserted over a 0.014 guidewire close to the constrained portion of the endoprosthesis to force deployment.Also this attempt remained unsuccessfully.Thirdly it was tried to cannulate the constrained portion without any success.Fourthly the delivery catheter was cut outside of the 12fr introducer sheath and a smaller sheath was inserted with the unsuccessful attempt to remove the partial deployed endoprosthesis from the patient¿s vessel.Finally the partial deployed endoprosthesis was retrieved into the proximal superficial femoral artery by using a snare device where the device was surgically removed.It was stated that the lesion was repaired with a patch.The procedure was successfully completed by implanting two gore® viabahn® endoprostheses (10mm x 10cm).It was stated that the second gore® viabahn® endoprosthesis was needed to be implanted in order to treat a vessel dissection which occurred based on the deployment difficulties of the first used medical device.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL EAST B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6975481
• MDR Text Key: 91102003
• Report Number: 2017233-2017-00551
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Catalogue Number: PAH101502E
• Device Lot Number: 17178072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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 Age: 79 YR