MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number GWBC30

Device Problem Torn Material (3024)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/11/2018

Event Type  Death  

Manufacturer Narrative

The product was not returned, therefore no product analysis can be performed.Without return of the product, a conclusive cause cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, after deploying the valve to 80%, hypotension was noted.It was suspected that while crossing the valve with the wire, the wire may have been advanced through the leaflet, so when the valve was deployed to 80%, it tore the leaflet.An angiogram also confirmed that the right coronary artery was not filling.The valve was recaptured and was removed from the patient.The procedure was converted to an open procedure for repair and a perforation in the posterior left ventricle was noted.Subsequently, the patient expired.The cause of the perforation could not be confirmed.It was to be due to the working confida guidewire or the wire used to cross the valve.

Manufacturer Narrative

Additional information was received that the guidewire was not pre-shaped and that no resistance had been met while using the confida wire.Per the physician, the (straight) non medtronic wire was suspected to have perforated the native leaflet as it initially crossed the valve.However, the cause of the left ventricle perforation was unable to be confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7483353
• MDR Text Key: 107234232
• Report Number: 2025587-2018-01054
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 69 YR