MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION BALLOON; BALLOON AORTIC VALVULOPLASTY

Catalog Number 0204511

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problems Occlusion (1984); Regurgitation, Valvular (2335)

Event Date 02/22/2018

Event Type  Injury  

Event Description

The patient was taken to the cardiac catheterization lab for a transarterial aortic valve replacement (tavr).After placement of the aortic valve, post echocardiography with transesophageal echocardiography (tee) showed trace paravalvar regurgitation.The valve had a constricted appearance on fluoroscopy and the mean gradient across the valve measured at 17 mmhg.The procedure felt that this was too high of a gradient to leave and elected to proceed with balloon valvuloplasty.  a 20 mm true balloon was used to dilate the valve.The balloon was taken to high pressure but ruptured during inflation.Unfortunately, there was significant resistance in retrieving the balloon back into the 14 fr sheath.The team attempted to bring the entire system out as a unit thinking that the balloon was not retrievable from the artery.With significant retraction on the system the balloon dissociated from the balloon catheter and became lodged in the external iliac artery.  several maneuvers were attempted to remove the balloon including upsizing to a 16fr sheath and snaring from the ipsilateral side and retrieval with a bioptome.Unfortunately the material appeared to be compressed in the external iliac artery and we could not retrieve it.  a dsa was taken of the iliac system showing occlusion of the external iliac artery.  the vascular surgery service was consulted.After discussions of potential options, the teams felt that surgical extraction of balloon material was going to be better option.The vascular surgeon performed surgical extraction of balloon material.

• Brand Name: TRUE DILATATION BALLOON
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 7333663
• MDR Text Key: 102239062
• Report Number: 7333663
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

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: Physician
• Device Catalogue Number: 0204511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 87