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

Model Number T505C223

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Dizziness (2194)

Event Date 12/06/2013

Event Type  Injury  

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the valve appeared slightly distorted with the stent posts deflected.All leaflets were slightly stiff but flexible, except where host tissue extended on the inflow and outflow.A small abrasion through the free margin and lunula of the left cusp adjacent to the non-coronary left commissure appeared to be due to contact with the bias cloth along the stent post.The free margin of the non-coronary cusps appeared to fold back and adhere to the host tissue on the outflow.A small fenestration measuring 1.5 millimeters was observed in the lunula of the left cusp.Small tears through the free margins of the right and non-coronary cusps on the top of the right non-coronary commissure appeared to be damage associated with explant.The non-coronary left and left right commissures were intact.Small tears on the top of the right non-coronary commissure appeared to have occurred during explant.Glistening off-white pannus partially covered the sewing ring on the inflow, to the tissue and base stitching, into all inferior coaptive areas, along the inflow margin of attachment and one to five millimeters onto all cusps, reducing the i nflow orifice area.Pannus remained attached to the sewing ring on the outflow adjacent to the left cusp with remnants on the outflow rail adjacent to the right and non-coronary cusps.Brown thrombotic-appearing host tissue filled and stiffened the non-coronary cusp on the outflow.Radiography showed trace mineralization in the host tissue along the sewing ring.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.Based on the returned product analysis, the reported stenosis and high gradient could have led to thrombus filling the cusp outflow, resulting in an immobile leaflet.Also, the pannus noted on the inflow tissue area could have led to an insufficient effective orifice area and immobile leaflet and compromised forward blood flow.Pannus overgrowth and thrombus are an inherent risk of surgical valve replacement and are addressed in the device risk management files.Pannus (host tissue overgrowth) and thrombus are generally considered patient-related conditions.High gradients- and stenosis-related failure modes are addressed in the device risk management files.

Event Description

Medtronic received information that 11 months post implant of this bioprosthetic valve, the patient was noted to have high gradients (approximately 70mmhg) and stenosis.The patient was asymptomatic and was discharged.At 34 months post-implant, the patient's gradient was 120mmhg; the patient was still asymptomatic except for a report of lightheadedness.Subsequently the valve was explanted and replaced.No further adverse patient effects were reported.

Manufacturer Narrative

The device has been returned for analysis, the analysis is in progress.Once the analysis is complete, 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): 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: 4357336
• MDR Text Key: 12753592
• Report Number: 2025587-2014-01025
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2016
• Device Model Number: T505C223
• Device Catalogue Number: T505C223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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: 00063 YR
• Patient Weight: 78