MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number	200SH18
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Congenital Defect/Deformity (1782); Death (1802); No Information (3190)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.
Event or Problem Description
Medtronic received information that 10 days post implant of this pulmonary valved conduit, the device was replaced due to unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Medtronic received information that the device was explanted and replaced with a 20 mm pulmonary valved conduit due to high gradients and a residual ventricular septal defect.Following the replacement procedure, the patient returned from the operating room in kidney failure.Additional information was received that 31 days following implant the patient died.The cause of death was not received.There was no allegation against the valve or its function nor was there any allegation that the valve contributed to the patient¿s death.It is unknown if an autopsy was performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Common Device Name: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6814600
• Report Number: 2025587-2017-01460
• Device Sequence Number: 13702873
• Product Code: MWH
• UDI-Device Identifier: 00643169616868
• UDI-Public: 00643169616868
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: 01/24/2020
• Device Model Number: 200SH18
• Device Catalogue Number: 200SH18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/21/2017
• 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: 23 YR
• Patient Weight: 67