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

Catalog Number PAJR071502E

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was presented with a ruptured aneurysm in the left popliteal artery.The rupture and the resulted hematoma were intended to be treated with two gore® viabahn® endoprostheses, envisioned to stop the bleeding, and a surgical intervention to treat the ruptured aneurysm.It was reported to gore that the first gore® viabahn® endoprosthesis (pajr071502e) was implanted successfully.It was stated that also the second gore® viabahn® endoprosthesis (pajr081502e) was inserted and advanced without any difficulties to the target lesion.It was reported that when medical device deployment was initiated, deployment line tension and excessive force were experienced.A visual inspection of the gore® viabahn® endoprosthesis indicated that the endoprosthesis did not deploy at all.Therefore the decision was made to remove the device from the patient¿s vessel.During the removal attempt of the second gore® viabahn® endoprosthesis, a movement of the prior implanted first device into the hematoma was recognized.Based on the device movement, the second gore® viabahn® endoprosthesis was continued to be removed through the introducer sheath, where the first gore® viabahn® endoprosthesis was explanted through open surgery.The procedure was completed by treating the patient¿s aneurysm rupture and hematoma via open surgery.It was stated that the patient was doing well after the procedure.

Manufacturer Narrative

The previous reported medical device engineering evaluation result belongs to the second gore® viabahn® endoprosthesis which was used during the procedure.For this medical device (pajr081502e) a deployment line tension and excessive force were reported.Subsequently, a visual inspection of the device indicated that the endoprosthesis did not deploy at all.Therefore the decision was made to remove the device from the patient¿s vessel.Due to the deployment failure, this device (pajr081502e) was returned to gore and evaluated.The medical device (pajr071502e) which belongs to the reportable part of the incident, due to an allegation of device migration resulting in a reintervention, was discarded at the facility.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation showed following: a pair of hemostats were returned, but not evaluated as they are not a gore product.The deployment line had been pulled, leaving 44 cm of deployment line between the deployment knob and hub.The outer braided constraining line was deployed completely, up to the tip-end of the endoprosthesis.The endoprosthesis remained fully constrained.Approximately 0.4 cm of the distal shaft, on which the endoprosthesis is mounted, was exposed at the transition.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: 7124880
• MDR Text Key: 95172554
• Report Number: 2017233-2017-00652
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• 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,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2019
• Device Catalogue Number: PAJR071502E
• Device Lot Number: 15215535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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): Required Intervention
• Patient Age: 59 YR