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

Catalog Number JHJR060202J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Pseudoaneurysm (2605)

Event Date 04/09/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative/corrected data: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2017, this patient presented with pseudoaneurysm of the splenic artery due to iatrogenic pancreatic fistula.There was also pancreatic pseudocyst (approximately 4 cm in length).A gore® viabahn® endoprosthesis (jhjr080502j) was implanted for hemostasis.The pancreatic pseudocyst was covered, however, the pseudoanerusym was not covered by the endoprosthesis.Another gore® viabahn® endoprosthesis (jhjr060202j) was deployed distal to the first endoprosthesis.After that, a type iii endoleak from the overlap of the endoprostheses was observed.A bare metal stent (non-gore device) was additionally implanted to reline the endoprostheses.The procedure was concluded, and the patient tolerated the procedure.On (b)(6) 2017, it was confirmed that the endoprostheses were occluded.The patient was asymptomatic, and the physician elected to monitor the patient.The physician reportedly considered that poor run-off of the splenic artery was the cause of the occlusion.

• 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: douglas rhodes ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6535052
• MDR Text Key: 74115714
• Report Number: 2017233-2017-00240
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Catalogue Number: JHJR060202J
• Device Lot Number: 14857584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR