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

Model Number	200SH
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 5 years 8 months post implant of this pulmonary bioprosthetic valved conduit in this pediatric patient, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) due to severe symptomatic conduit stenosis.The valve appeared heavily calcified with severe stenosis ¿ peak gradient of 90 mm hg by echocardiogram.By catheter it was noted to be 50 mm hg gradient across the conduit with an rv pressure of 70 mm hg (80% systemic).No additional adverse patient effects were reported.

• Brand Name: CONTEGRA
• Common Device Name: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7138013
• Report Number: 2025587-2017-02522
• Device Sequence Number: 1068994
• Product Code: MWH
• UDI-Device Identifier: 00613994600189
• UDI-Public: 00613994600189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: 12/12/2013
• Device Model Number: 200SH
• Device Catalogue Number: 200SH18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/21/2017
• 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: 10 YR
• Patient Weight: 33