MAUDE Adverse Event Report: HEART VALVES SANTA ANA CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number PVC214DR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 09/01/2003

Event Type  Injury  

Event Description

Medtronic received information from a technical services call that this pulmonary valved conduit was surgically explanted 11 months post implant due to stenosis.A medtronic pulmonary valved conduit was implanted into the same position.No further adverse patient effects were reported.

Manufacturer Narrative

It was reported that the explant occurred (b)(6) 2003; the exact date is not known.Product analysis: no product was returned, therefore no product analysis can be performed.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.As this device was not returned for evaluation, a failure mechanism was not able to be determined.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 4502619
• MDR Text Key: 16070339
• Report Number: 2025587-2015-00184
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVC214DR
• Device Catalogue Number: PVC214DR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00013 YR