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

Model Number	T510C27
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Information (3190)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product analysis is currently in progress.Upon completion of the product analysis, a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that immediately after implanting this bioprosthetic valve, the surgeon noted a leak along the annulus of the valve on the inside of the right trigone marker.The valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed small needle holes and damage in the sewing ring.All leaflets were in the closed position.A large cut through the tunica of the right cusp (inflow) was observed which is consistent with a puncture or laceration by a sharp instrument such as forceps or scalpel.The right cusp exhibited cut-like damage on the tunica and the tunica could be lifted off the surface.The tissue area adjacent to the base stitching also exhibited a puncture like damage across the tunica.All commissures were intact.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Each valve must pass flow, coaptation and tissue characteristic requirements prior to release for distribution.Testing of this valve showed the valve met specification, and the root cause of the reported leak could not be confirmed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed there was sewing ring damage in the form of small needle holes.All leaflets were in the closed position.A large cut through the tunica of the right cusp (inflow) was observed which appear to be consistent with a puncture or laceration by a sharp instrument such as forceps or scalpel.The right cusp exhibited a cut like damage on the tunica.The tunica could be lifted off the surface.The tissue area adjacent to the base stitching also exhibited a puncture like damage across the tunica.All commissures were intact.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The valve met the performance specifications for regurgitant fraction.Based on the returned product analysis and received information, the reported leak cannot be confirmed with the coaptation tester and function testing, and the root cause of the leak cannot be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that immediately after implanting this bioprosthetic valve, the surgeon noted a leak along the annulus of the valve on the inside of the right trigone marker.The valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported. .

• Brand Name: HANCOCK II MITRAL 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: 7722595
• Report Number: 2025587-2018-01879
• Device Sequence Number: 19092757
• Product Code: LWR
• UDI-Device Identifier: 00643169594401
• UDI-Public: 00643169594401
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 08/27/2020
• Device Model Number: T510C27
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 09/17/2018; 09/17/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/03/2018; 10/03/2018
• 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: 39 YR