MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number	505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); No Information (3190)
Date of Event	10/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, but no new information has been received to date.The device has not been received for analysis.Without the receipt 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 or Problem Description
Medtronic received information that two years, ten months post implant of this aortic mechanical valve, the device was explanted and replaced with a bioprosthetic valve.The reason for replacement was not reported.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that the patient presented with complete heart block (chb) and ventricular tachycardia.A transesophageal echocardiogram (tee) revealed a rocking motion of the device which indicated endocarditis.The device was explanted and replaced with a bioprosthetic valve after significant debridement of the aortic annulus.No further adverse patient effects were reported.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.
Additional Manufacturer Narrative
Conclusion: additional information was received that 2 years and 10 months post implant of this mechanical valve; it was explanted due to endocarditis.The organism was not provided.The operation note states that the patient had severe myocardial and pericardial adhesions.The patient had a grossly infected and necrotic aortic annulus.The mechanical valve then essentially fell out with no significant pulling or problems.Per the available information, there was no evidence of valve involvement of the endocarditis.Based on the dhr review of this product, there was no issue identified regarding manufacturing and sterilization that would have impacted this event.No issues were identified on the sterilization process.The biological indicator (bi) sterility testing on the sterilization load confirms the sterility (sal = 10-6) for the device.In addition, based on the reported information, there is no evidence of the endocarditis could have been contributed by the device.Valid scientific evidence supports no valve-related cause for endocarditis where implant time exceeds two months.Ref: 21 cfr 803.20 (c) (2), and interventional and surgical cardiovascular pathology, isbn 0-7216-2457-x, p.38 and p.142.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC AP
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6142269
• Report Number: 3008592544-2016-00065
• Device Sequence Number: 1075396
• Product Code: LWQ
• UDI-Device Identifier: 00613994959973
• UDI-Public: 00613994959973
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2016
• Device Model Number: 505
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/27/2017
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/26/2017; 01/27/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 82