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

Model Number 510

Device Problem Material Perforation (2205)

Patient Problem Discomfort (2330)

Event Date 05/28/2015

Event Type  Injury  

Event Description

Medtronic received information that two years and two months post implant of this bioprosthetic valve, the valve was explanted due to leaflet perforations, which caused patient discomfort.No adverse patient effects were reported.

Manufacturer Narrative

Patient weight was requested but unavailable.Product analysis: the device was discarded by the customer, therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was received that this valve also exhibited mild paravalvular regurgitation.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.Photos of the valves were sent to medtronic.A conclusive cause of the tear cannot be determined due to the quality of the photos.However, the photos suggest that host tissue / pannus formed a large lump in the location that the leaflet was flexing against, which could cause wear on the leaflet.Also, a light coating of pannus was noted on the leaflet (inflow side) above the hole.The pannus may have created a hinge point, with the leaflet flexing along the pannus rather than at the margin of attachment.This would exacerbate fatigue of the tissue at this location.The reported regurgitation is most likely due to the cuspal tear and perforation.The pannus overgrowth could be a potential cause of the cuspal tear.Pannus formation is an inherent risk of surgical valve replacement.(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): MEDTRONIC HEART VALVES DIVISION; 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: 4887831
• MDR Text Key: 6066271
• Report Number: 2025587-2015-00719
• 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,Followup
• Report Date: 07/02/2015

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: 11/04/2017
• Device Model Number: 510
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided; 07/02/2015
• Supplement Dates FDA Received: 07/27/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2012
• 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: 00063 YR