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

Catalog Number PAC060502

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

Patient Problem Aneurysm (1708)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.(b)(4).Our engineers have evaluated the returned device.Their investigation showed following: the deployment knob was pulled 22.7cm away from the hub.A kink was noted at the transition of the delivery catheter.The outer braided constraining line and 0.5cm of the inner braided constraining line were deployed.One half centimeter of the tip/distal end of the endoprosthesis was expanded.Traction on the deployment line resulted in further deployment of the device during the evaluation.Based on the device examination performed, no manufacturing anomalies were identified.Based on the observation from the engineer from october 24, 2016, the reportability for this medical device incident was reassessed and discrepancy regarding provided event description wand investigation results was documented.

Event Description

On an unknown date the patient was treated with a fenestrated aortic prosthesis to treat an abdominal aortic aneurysm.Both renal arteries, the superior mesenteric artery and the celiac trunk (left gastric and splenic artery) were treated with bare metal stents which were connected to the aortic prosthesis.During a patients follow up procedure it was recognized, that all five implanted bare metal stents were disconnected from the aortic prosthesis.Therefore the decision was made to implant five gore® viabahn® endoprostheses to bridge the region between the disconnected bare metal stents and the aortic prosthesis.It was reported to gore that when device deployment of one gore® viabahn® endoprosthesis, on an unknown artery, was initiated the device did not deploy at all.The decision was made to remove the medical device through the introducer sheath and the procedure was completed implanting another gore® viabahn® endoprosthesis.The patient did not experienced any serious injury due to the deployment failure.It was stated that the other four gore® viabahn® endoprosthesis were successfully implanted and that the physician was satisfied with the outcome.

• 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 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6056533
• MDR Text Key: 58815535
• Report Number: 2017233-2016-00825
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/24/2016

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: 09/27/2018
• Device Catalogue Number: PAC060502
• Device Lot Number: 14523827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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): Other
• Patient Age: 79 YR