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

Model Number GWBC30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the guidewire was inspected and the tip of the guidewire was not manipulated prior to use.The guidewire was introduced into the ventricle through an already positioned 6 french(fr) pigtail catheter and placed in the apex of the left ventricle.While exchanging wires and catheters during crossing of the annulus into the left ventricle (lv), hypotension was noted.The guidewire position was visually monitored with no resistance felt during use.It was thought that the hypotension was caused by aortic insufficiency.This delivery catheter system (dcs) was passed over the guidewire into the patient.Prior to crossing the arch with the dcs, blood pressure remained low.The valve was deployed to 80% however blood pressure remained low.No movement of the guidewire was observed during valve release.The valve was recaptured and the system was removed.Echocardiogram was performed.The hypotension was treated with blood transfusion and initiation of bypass.The procedure was converted to surgery where a small perforation was noted in the back wall of the lv.The perforation was repaired successfully.It was unknown if the perforation was caused by the guidewire.Per the physician, the patient's left ventricular hypertrophy may have contributed to the event.No additional adverse patient effects were reported.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14465631
• MDR Text Key: 293266805
• Report Number: 2025587-2022-01431
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• 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: 04/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female