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

Model Number T505C2136

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Medtronic received information that the patient implanted with this bioprosthetic aortic heart valve had presented for replacement of his native mitral and aortic valves due to regurgitation.The preoperative diagnosis following a transesophageal echocardiogram was calcific degeneration for both native valves, in addition to active infective endocarditis of the native aortic valve.During surgery, the atrial valve was confirmed to be heavily calcified and infected, and the mitral valve was moderately calcified.Both native valves were successfully replaced with bioprostheses with no issues.The patient was discharged, but re-presented six days after the procedure; an echocardiogram showed severe central aortic regurgitation and aortic insufficiency with this device.Upon reopening the original access site, the operative team did not observe any impingement of the device leaflets or damage to the valve.A review of the echocardiogram and photos of the device in situ showed that the valve appeared to be well-seated with coapting leaflets and no paravalvular leak, with no obvious issues for the patient symptoms.The decision was made to explant this valve and replace it with another valve of the same size and model.It was suspected that this device had experienced an unidentified mechanical failure.Medtronic received information two weeks after the reoperation that the patient subsequently passed away due to an unknown cause; the date of the death was not reported (the reported date of death in this report is an estimate, pending receipt of additional information).The physician indicated that although the valve was not directly involved with the patient¿s death, the reoperation and replacement one week after its implant was a contributing factor.There were no issues reported to date with either the second aortic bioprosthesis or the mitral bioprosthesis.

Manufacturer Narrative

Additional information has been requested.It was reported that the device will be returned for analysis, along with photographs and copies of procedural images.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Event Description

M.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was discolored showing evidence of blood contact.The valve was slightly distorted; oval shaped.Green and white filament sutures remained attached to the sewing ring.All leaflets were slightly stiff but flexible possibly due to blood contact and/or the decontamination process.All leaflets were intact.The free margins were slightly wavy which may be the result of the stent distortion and/or deflected stent posts.All commissures were intact.There was no evidence of host tissue.Radiography showed no evidence of mineralization in the valve; trace mineralization was observed along the sewing ring.Conclusion: the device history record (dhr) 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.Review of the echocardiogram showed that the valve was well seated with severe aortic regurgitation.Significant anterior and posterior para-prosthetic jets were demonstrated; it is unclear whether these two jets were solely responsible for the observed aortic regurgitation.The left ventricular (lv) outflow tract functional anatomy following the double valve replacement appeared abnormal, with both anatomic and functional evidence of subvalvular lv outflow obstruction.Over an extended period, subvalvular lv outflow turbulence can lead to (native or bioprosthetic) aortic leaflet sclerosis and retraction, with ensuing aortic regurgitation.The time course for this seems premature only 1 week after aortic/mitral valve replacement.Inspection of the valve leaflets would be expected to reveal anatomic changes from exposure to the turbulent jet.Based on the received information, echocardiogram review and the returned product analysis, the valve distortion seen at analysis could be a contributing cause to the regurgitation.However, the echo did not provide conclusive evidence that the valve distortion was the root cause of the regurgitation.Exactly when and how the distortion occurred cannot be determined; however per medtronic¿s procedure each hancock ii valve is inspected for distortion and the dhr confirmed this valve passed the inspection prior to release for distribution.At this time, no solid root cause has been determined for the reported clinical observation.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK
• 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: 4190381
• MDR Text Key: 17635772
• Report Number: 2025587-2014-00777
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T505C2136
• Device Catalogue Number: T505C2136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00075 YR