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

Model Number T505C221

Device Problems Calcified (1077); Gradient Increase (1270); Structural Problem (2506)

Patient Problems Corneal Pannus (1447); Thrombus (2101)

Event Date 01/11/2014

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory the valve appeared slightly distorted; oval shaped.All leaflets were stiff due to host tissue on the inflow and outflow.Tiny tears on the tunica along the inflow margin of attachment of right and non-coronary cusps appeared to be associated with the removal of host tissue during explant.All commissures appeared intact.A remnant of glistening off white pannus attached to the sewing ring on the inflow adjacent to the non-coronary cusp extended over the tissue and base stitching and 1 to 2 mm onto the inflow.A remnant of pannus remained attached to the outflow rail adjacent to the right cusp.Tan thrombotic appearing host tissue filled and stiffened all leaflets on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: based on the information received and the returned product analysis, the high gradient could have resulted in the abundant thrombus filling the cusp outflow that caused immobile leaflet.High gradient due to immobile leaflets caused by thrombus / pannus is a known failure mode.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.(b)(6).

Event Description

Medtronic received information that this bioprosthetic aortic heart valve was explanted after approximately nine months due to high gradients and an observation of the valve having thrombosed.During explant, it was observed that the valve leaflets had thickened and were non-pliable, with areas of pannus overgrowth and calcification.The valve was replaced with another manufacturer¿s mechanical heart valve.No adverse patient effects beyond reoperation were reported.

Manufacturer Narrative

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 product has been returned and analysis is in progress.Upon completion of analysis, a supplemental 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 AORTIC 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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3628599
• MDR Text Key: 11698327
• Report Number: 2025587-2014-00036
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2014
• Device Model Number: T505C221
• Device Catalogue Number: T505C221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2011
• 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: 00079 YR