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

Model Number PVC200

Device Problem Calcified (1077)

Patient Problems Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted.Conclusion: 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.(b)(4).

Event Description

Medtronic received information that 9 years and 10 months post implant of this bioprosthetic valved conduit, it was replaced valve-in-valve with a larger transcatheter valve.9 years and 9 months post implant, the patient presented with bilateral lower extremity edema.Computed tomography (ct) scan revealed calcification with narrowing of the conduit.Significant right ventricle pulmonary artery stenosis was suspected.No further adverse patient effects were reported.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5357986
• MDR Text Key: 35569163
• Report Number: 2025587-2016-00036
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2006
• Device Model Number: PVC200
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00010 YR