MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAHR080501E

Device Problem Migration (4003)

Patient Problem Embolism (1829)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2015, a gore® acuseal vascular graft was implanted to create a venous anastomosis between the femoral artery and the femoral vein as an access option for dialysis.On (b)(6) 2018, the patient presented with a stenosis at the venous anastomosis region.A gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.On (b)(6) 2018, follow-up imaging revealed that the gore® viabahn® endoprosthesis had migrated.On (b)(6) 2018, follow-up imaging showed that the device had migrated into the patient's left pulmonary artery.The patient expired on (b)(6) 2019, due to renal failure as well as critical limb ischemia.According to the physician the death was asymptomatic and was not related to the migrated gore® viabahn® endoprosthesis.

Manufacturer Narrative

B5: updated h6: added method code 2, updated conclusion code 1 intra-operative angiographic images dated (b)(6) 2018, post-operative angiographic images dated (b)(6) 2018 and a chest x-ray image dated (b)(6) 2018 were provided to gore for evaluation.The evaluation showed the following results: - (b)(6) 2018: the intra-operative image illustrates what appears to be an occlusion proximal to the previous implanted viabahn.- (b)(6) 2018: the post-operative image illustrates what appears to be an additional viabahn device placed at the level of the previous occlusion.- (b)(6) 2018: a chest x-ray in anterior-posterior view illustrates that the viabahn has migrated to the heart.

Event Description

The following was reported to gore: on (b)(6) 2015, a gore® acuseal vascular graft was implanted to create a bypass between the femoral artery and the femoral vein as an access option for dialysis.On an unknown date, a gore® viabahn® endoprosthesis was implanted due to unknown reasons.On (b)(6) 2018, the patient presented with a stenosis at the venous anastomosis region proximal to the previous implanted gore® viabahn® endoprosthesis.Another gore® viabahn® endoprosthesis was implanted as a prophylaxis against graft thrombosis secondary to outflow stenosis.The device bridged from the femoral vein into the gore® acuseal vascular graft.On (b)(6) 2018, follow-up imaging revealed that the gore® viabahn® endoprosthesis had migrated.On (b)(6) 2018, follow-up imaging showed that the device had migrated into the patient's left pulmonary artery.The patient expired on (b)(6) 2019, due to renal failure as well as critical limb ischemia.According to the physician the death was asymptomatic and was not related to the migrated gore® viabahn® endoprosthesis.

Manufacturer Narrative

G5: changed to yes.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8499398
• MDR Text Key: 141460114
• Report Number: 2017233-2019-00231
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Catalogue Number: PAHR080501E
• Device Lot Number: 18236728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 71