MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA073901A

Device Problem Deflation Problem (1149)

Patient Problem No Code Available (3191)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the gore: on (b)(6) 2020, the gore® viabahn® vbx balloon expandable endoprosthesis was placed in the patient's superficial femoral artery as intended.The disease state treated is unknown.The device was inflated with no issue, however, the device did not deflate.The doctor attempted several techniques to deflate the device with no success.The device was pulled back into the iliac and the physician cut down the vessel to remove the device.The doctor commented that it appeared the balloon was adhered to the inner lumen of the stent.

Manufacturer Narrative

Engineering evaluation: the returned device was identified to be a 7 x 39 mm configuration.The gore® viabahn® vbx balloon expandable endoprosthesis returned expanded.It remained in the mounted location; however, the balloon was deflated.The delivery system arrived with no hub (appeared to have been cut) and the catheter remained in a non-gore introducer sheath.The proximal end of the balloon was pulled to the edge of the introducer sheath and deformed the distal end of it.The first ring on the endoprosthesis proximal end was bent.The endoprosthesis slid off the deflated balloon and the delivery system was removed from the introducer sheath.The previously exposed catheter showed three kinks with two necked portions.The portion of the catheter removed from the introducer sheath was necked for a significant portion of the length, which prevented an 0.035¿ guidewire from passing through the lumen.Due to the event description, it is not believed that the catheter damage observed contributed to the inability to deflate, but rather, was a result of the clinical situation.In manufacturing, each device is 100% verified in process to inflate and deflate.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.After the visual observations were made, cleaning was performed, and a stem tube was bonded to a cut portion of the dual lumen catheter to facilitate gluing a new hub onto the delivery system.This allowed further evaluation of the balloon.Using a slow manual deflation (per ifu), the balloon was successfully inflated with water to 12 atm (nominal) and deflated.The reported complaint was not observed, and the device performed as expected when a slow manual deflation was used.However, repeating the inflation and attempting a quick pull deflation with the endoflator (not as described in ifu) did recreate the inability to deflate, as reported.This phenomenon was overcome by repressurizing the endoflator up to 12 atm and slowly manually deflating.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Added d4 - device information (catalog number, expiration date, serial number, udi).Added h4 - device manufacture date.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10809829
• MDR Text Key: 215323789
• Report Number: 2017233-2020-01429
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Catalogue Number: BXA073901A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Patient Sequence Number: 1