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

Model Number T505

Device Problem Material Rupture (1546)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 2 years post implant of this bioprosthetic valve, the patient presented with shortness of breath and echocardiogram showed minimal aortic insufficiency (ai).Thirty five months post implant, the ai had become severe and the valve was explanted with no adverse patient effects reported.Prior to explant, the echocardiogram showed a tear in the leaflet.

Manufacturer Narrative

Medtronic received additional information that the physician reported the valve was explanted due to endocarditis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: a review of the device history record (dhr) was performed for this valve; this device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.Without the return of the device, the root cause of the regurgitation and cuspal tear cannot be determined.Based on the available received information, the endocarditis may have cause the regurgitation.The medtronic tissue bioprosthetic heart valve product manufacturing processes involves a series of tissue treatments to fix the tissue and to reduce the bioburden level prior the terminal sterilization step to yield a sterile product.The sterilization process has an anti-microbial kill on the microorganisms, and it also has demonstrated the ability to inactivate the biological indicator, bacillus atrophaues atcc 9372 which is representative bioburden for the microbial flora found in our manufacturing controlled environment.In addition, this event the occurrence of endocarditis was greater than 12 months post implant (35 months).Based on the descriptive comments outlined from the journal literature, complaints which occurred greater than 12 months post implant were largely considered to be community acquired (refer to note 1).Therefore, it was highly unlikely that the endocarditis originally came from the device and/or manufacturing valve process.Note 1 - mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.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 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: 6778541
• MDR Text Key: 82356619
• Report Number: 2025587-2017-01358
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505U227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• 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: 61 YR