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

Model Number T505C225

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombus (2101)

Event Date 10/07/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 45 months after implant, this bioprosthetic valve was explanted due to aortic stenosis after the patient presented with shortness of breath and the valve exhibited increased gradients during diagnostic testing.At explant, thrombus was observed on two of the three device leaflets.There also was an observation of pannus at the annular level.The explanting facility was to conduct pathological testing prior to returning it to medtronic for analysis.No subsequent adverse patient effects were reported.

Manufacturer Narrative

It was reported that the device will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Manufacturer Narrative

Additional information was received that the physician noted upon explant a visual anomoly regarding the stent covering (polyester m aterial) appeared to not be properly placed over the valve stent.Also noted was a large muscle shell on the valve tissue.The product return has been requested, however the device has not been returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

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.Without the product return, a root cause of the high gradient / stenosis cannot be determined.Pannus overgrowth is an inherent risk of surgical valve replacement.Reduced performance of the valve is attributed to thrombus and host tissue overgrowth.These findings are generally considered a patient-related condition.

Manufacturer Narrative

Date of event was incorrectly reported as (b)(6) 2011.This has been changed to (b)(6) 2014, the date of explant.

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: 4239900
• MDR Text Key: 5062514
• Report Number: 2025587-2014-00864
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2015
• Device Model Number: T505C225
• Device Catalogue Number: T505C225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2010
• 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): Hospitalization; Required Intervention