MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number VBH070502W

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

The following records were reviewed for this case: 21452766, 21484534, qc testing batch 1-2-20-b, qc testing batch 1-15-20-a, 21454335, 21502772, 21498565.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The physical investigation of the device confirmed the physician¿s observation that the zipper would not continue deployment when the deployment knob was pulled.Partial device expansion of 3 mm was observed during physical evaluation of the returned final assembly.The root cause for the deployment difficulty could not be determined.Intended use / indications state, the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 ¿ 12 mm.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6), 2020 a patient was implanted with a 7mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface to treat internal carotid artery dissecting aneurysm.The viabahn device was advanced via 8 fr sheath over guidewire to target lesion.After the physician confirmed the accurate positioning, he deployed the viabahn device while the sheath was retracting.When the physician pulled the deployment line, he found the viabahn device got stuck and could not be deployed after many attempts.Therefore, the physician retracted the viabahn device out of the patient.Another viabahn device with same size was used to complete the procedure successfully.The patient did not experience any adverse consequences.The viabahn device couldn't be deployed out of patient.During the product evaluation, the engineer observed the device partial expansion of 3 mm.

Manufacturer Narrative

H6: update investigation conclusions 4315 and 24 to 4315.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11795226
• MDR Text Key: 249990311
• Report Number: 2017233-2021-01960
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: 12/29/2022
• Device Catalogue Number: VBH070502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/08/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 63