MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAH070502

Device Problems Break (1069); Migration or Expulsion of Device (1395); Premature Activation (1484); Difficult to Remove (1528); Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a gore viabahn endoprosthesis was being used in a chimney procedure with a cook evar device in the renal artery up into the aorta.The cook evar cuff was deployed first and then the gore viabahn endoprosthesis was being deployed.The access site for the viabahn device was in the arm.It was reported to gore that as the gore viabahn endoprosthesis was halfway deployed, the deployment line became stuck and broke.It was stated that the viabahn device moved out of the renal artery.As the physician was trying to snare the viabahn device, it fully deployed in the thoracic aorta.The gore viabahn endoprosthesis was removed from the femoral artery access site.The broken deployment line was still caught on a strut of the cook device.From the access point in the arm, a guiding catheter was used over the deployment line in an attempt to detach the line from the strut.As pressure was applied to the strut with the catheter, the deployment line broke again.This process was repeated a few times and the deployment line continued to break.The deployment line ended up being left inside the patient.The procedure was completed by using an atrium stent.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.An explant analysis is currently being performed.

Manufacturer Narrative

(b)(4): the engineering evaluation stated that the following observations were made: the endoprosthesis and three segments of deployment line were returned to histology without the delivery catheter.The endoprosthesis was secured in the snare used to retrieve it and was unremarkable.The snare is not a gore product, and as such, was not evaluated.One segment of deployment line was tied to a multi-filament black thread of unknown origin.The deployment line fragments measured approximately 65cm, 19cm, and 7cm in length.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4838574
• MDR Text Key: 16863911
• Report Number: 2017233-2015-00352
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2015

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: 10/06/2017
• Device Catalogue Number: PAH070502
• Device Lot Number: 13366038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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: 71 YR
• Patient Weight: 104