MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	DLA
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on (b)(6) 2016 that a patient with mitroflow valve (dla19, s/n (b)(4) presented to the emergency room with worsening shortness of breath and orthopnea, upon examination it was found that the patient had severe aortic stenosis with a peak gradient of 71mmhg.A new perceval valve was implanted size small and post procedure showed no perivalvular leaks or central leaks and showed a peak gradient of 14mmhg and mean of 4mmhg.
Additional Manufacturer Narrative
The following were changed: device available for evaluation?-no.(b)(4).

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6091437
• Report Number: 3004478276-2016-00139
• Device Sequence Number: 1666176
• Product Code: DYE
• UDI-Device Identifier: 00896208000153
• UDI-Public: (01)00896208000153(240)DLA19(17)170630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060038/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: DLA
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 04/06/2017
• 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: 67 YR
• Patient Weight: 81