MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	T505C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fistula (1862); Regurgitation, Valvular (2335)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Medtronic received information that following the implant of this bioprosthetic valve, transesophageal echocardiogram (tee) revealed an annular fistula to the right atrium.Bypass was re-initiated and the valve was explanted and replaced.A pericardial patch to the aortic annulus and the right atrial septal wall was placed.The electrocardiogram (ecg) showed complete heart block (chb) resolved with temporary pacing.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that 3 days post valve implant a permanent pacemaker was implanted for complete heart block (chb).The physician also reported the annular fistula was completely a consequence of one of the annular sutures pulling through when the valve was secured, resulting in a very small tear at the subannular/annular level with direct communication into the right atrium, and was a surgical technical issue independent of the prosthesis.The physician reported the patient had an otherwise uncomplicated course and full recovery after surgery.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6951963
• Report Number: 2025587-2017-01847
• Device Sequence Number: 683031
• Product Code: LWR
• UDI-Device Identifier: 00643169594326
• UDI-Public: 00643169594326
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: T505C
• Device Catalogue Number: T505C227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 04/12/2018
• 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: 80 YR
• Patient Weight: 66