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

Model Number PVC200S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Insufficiency, Valvular (1926)

Event Date 05/14/2015

Event Type  Injury  

Event Description

Medtronic received information that immediately post implant of this bioprosthetic valved conduit, the product was replaced due to r egurgitation observed by the implanting physician.No other adverse patient effects were reported.

Manufacturer Narrative

Multiple attempts to obtain additional details regarding this patient and event have been unsuccessful.The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the returned device was returned in its original packaging, submerged in clear solution.The returned device did not appear to have been implanted.Visual inspection confirmed that the device was received whole.All leaflets were flexible and intact.All commissures were intact.Manufacturing personnel examined the device and no anomalies were identified.The device was filled with fluid and the fluid stayed in the device for more than 10 seconds.The device was deemed acceptable.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.Analysis of the returned product could not confirm the reported regurgitation.

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): 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: 4838782
• MDR Text Key: 18034579
• Report Number: 2025587-2015-00646
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2017
• Device Model Number: PVC200S
• Device Catalogue Number: 200SH20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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