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	Death (1802); Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Perforation (2001)
Date of Event	01/08/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: ev olutpro-29-us, serial #: (b)(4), ubd: 04-sep-2021, udi#: (b)(4).Product analysis: the guidewire was discarded and the valve remains implanted therefore no product analysis can be performed.Conclusion: without the return of the products, 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 following the implant of this 29mm transcatheter bioprosthetic valve, using a 6 fr dilator with this guidewire, the blood pressures were low and did not improve.A contrast injection in the left ventricle showed extravasation from a perforation at the apex of the heart.A pericardiocentesis was performed and the patient was transferred to the operating suite to repair the perforation.Attempts to suture the perforation caused micro tears due to the patient¿s friable tissue.Following the attempt to surgically repair the ventricle, the patient died.Per the physician, the perforation likely occurred during valve deployment with forward pressure on the confida guidewire in a very fragile, extremely small ventricle with friable tissue due to the patient's medical history.It was unknown whether an autopsy was performed.

• 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: 9611456
• Report Number: 2025587-2020-00214
• Device Sequence Number: 524131
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 09/30/2021
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91704107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/21/2020
• 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: Death
• Patient Age: 84 YR
• Patient Weight: 107