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

Model Number	GWBC30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the guidewire was discarded, therefore no product analysis can be performed.Conclusion: without 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 or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve and delivery catheter system (dcs) were advanced across the aortic annulus.The patient became hypotensive.A temporary pacer was attempted to be place, but there were positioning difficulties.The physician removed the evolut system and exchanged it for a 16 fr sheath.It was thought that the guidewire and evolut system were contributing to the hypotension by keeping the native valve open.The pressure did not recover.An echocardiogram revealed a pericardial effusion.An angiogram revealed a perforation in the apex of the left ventricle.The physician attempted an open repair by placing patches at the apex.It was reported that the tissue was friable because it was difficult for the surgeon to patch.The patient was stable at the end of the repair.No valve was ever implanted.Per the physician, the cause of the perforation was unknown.It was suggested that the straight wire during crossing of the native valve, or the guide wire during insertion of the evolut system may have caused the perforation.The tip of the guidewire was not pre-shaped prior to use, it was unknown whether the guidewire was torqued or twisted, and it was reported that the physician did not articulate that he felt any resistance.The guidewire tip was monitored throughout the procedure for proper placement of the curve and distal tip.No additional adverse patient effects were reported. .

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9152084
• Report Number: 2025587-2019-03025
• Device Sequence Number: 19594679
• Product Code: DQX
• UDI-Device Identifier: 00763000060886
• UDI-Public: 00763000060886
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91807791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 61