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

Model Number T510C

Device Problem Gradient Increase (1270)

Patient Problem Valvular Stenosis (2697)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that approximately eight months post implant of this bioprosthetic mitral valve, an echocardiogram showed valvular stenosis and elevated gradients; the mean gradients measured were measured at 25 mmhg by echocardiogram.Subsequently, the valve was replaced.The patient spent twelve days in the intensive care unit (icu) following the replacement procedure.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The stent posts appeared slightly deflected.Remnants of chordae tendineae were observed along the sewing ring on the outflow.A pledget remained attached to the sewing ring on the outflow adjacent to the left right stent post.The non-coronary and left cusps were stiff due to host tissue that filled and stiffened the leaflets on the inflow and outflow.The right cusp appeared partially flexible except where host tissue extends on the outflow, and the right non-coronary commissure appeared intact.Host tissue covered both the non-coronary left and left right commissures making it slightly difficult to determine the condition.Pannus remained attached to the sewing ring on the inflow extending slightly onto the tissue and base stitching, into all inferior coaptive areas and 1 to 1.5 mm onto all cusps.Pannus lined the sewing ring and outflow rails adjacent to all cusps, to the back of right non-coronary stent post and tops of the two, extending over to the tops of all commissures, encapsulating the non-coronary commissure resulting with restricted leaf let motion.Pannus on the outflow rail extended over to the inner outflow rail to the outflow margin of attachment adjacent to all cusps.Brown thrombotic appearing host tissue filled and stiffened the non-coronary and left cusps on the outflow.Remnants of brown thrombotic appearing host tissue partially filled and stiffened the right cusp on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: a review of the device history record (dhr) was performed for this valve.There were no correlations / issues identified in regard to manufacturing that could be related to this event.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve causing the stenosis / high gradient.

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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5563769
• MDR Text Key: 42205329
• Report Number: 2025587-2016-00453
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: T510C
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided; 09/23/2016
• Supplement Dates FDA Received: 09/29/2016; 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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
• Patient Age: 00067 YR
• Patient Weight: 74