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

Model Number	PVC200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Pulmonary Edema (2020)
Date of Event	04/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.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 an unknown duration post implant of this 14 mm bioprosthetic valved conduit, the patient arrested at home due to ongoing issues with respiratory support and pulmonary edema/hemorrhage.Subsequently, the patient died.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received indicated that the patient died approximately 9 weeks post-implant.Added patient age ; patient weight; date of death.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: the dhr review was performed on the device; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Neither autopsy nor explant information was reported.With the limited information available, a relationship between the device and the death could not be established.No allegations were made relating the valve or its function to the death.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
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: 6651842
• Report Number: 2025587-2017-00995
• Device Sequence Number: 1082527
• Product Code: MWH
• UDI-Device Identifier: 00643169616905
• UDI-Public: 00643169616905
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2017

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: 03/02/2019
• Device Model Number: PVC200
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 06/25/2017; 07/27/2017; 07/27/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 07/05/2017; 08/14/2017; 09/07/2017
• 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: Death
• Patient Age: 9 MO
• Patient Weight: 8