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

Model Number T510C27

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Mitral Regurgitation (1964); Dizziness (2194)

Event Date 03/24/2014

Event Type  Injury  

Event Description

Medtronic received information that 4.5 years post-implant of this bioprosthetic valve, the patient presented with symptoms of dizziness and shortness of breath.An echocardiogram revealed moderate mitral regurgitation with a forward blood flow velocity of 3.2m/s.The valve leaflet looked atrophied on the echocardiogram.Additional information was received (b)(6) 2014 that the valve was explanted recently.It was reported that the explant date and device replacement were not available.No subsequent adverse patient effects were reported post-explant.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Regurgitation is a potential adverse event per the hancock ii instructions for use (ifu).Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3848834
• MDR Text Key: 4614880
• Report Number: 2025587-2014-00350
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2014
• Device Model Number: T510C27
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: 05/09/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2009
• 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: 00069 YR