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

Model Number PVC200

Device Problems Calcified (1077); Material Integrity Problem (2978)

Patient Problems Calcium Deposits/Calcification (1758); Non specific EKG/ECG Changes (1817); Stenosis (2263)

Event Date 05/16/2011

Event Type  Injury  

Manufacturer Narrative

Multiple attempts to obtain additional information and device return have been unsuccessful.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).

Event Description

Medtronic received information that following the implant of this right ventricle (rv) to pulmonary artery (pa) 12mm bioprosthetic valved conduit in a pediatric patient, 1st degree atrio-ventricular (av) block was noted.A medtronic dual-chambered epicardial pacemaker lead system was implanted 4-days post-conduit implant.Four years and 5 months post-implant, rv to pa conduit stenosis was noted.During explant the conduit was dissected; calcification and stenotic degenerated leaflets were noted.The conduit was replaced with an 18mm valved conduit of the same model in the rv to pa position; the device was cut as short as possible prior to implant.A transesophageal echocardiogram (tee) indicated no concerns.No adverse patient effects were reported.

Manufacturer Narrative

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.A true root cause for the reported 1st degree atrio-ventricular (av) block could not be determined from the reported information.Stenosis is a known adverse event.Valve calcification was reported, which likely caused the stenotic degenerated leaflets.However, without the return of the product, no definitive conclusion can be made regarding the clinical observations.

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: 5247791
• MDR Text Key: 32087139
• Report Number: 2025587-2015-01232
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2015

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: 07/22/2013
• Device Model Number: PVC200
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; 12/15/2015
• Supplement Dates FDA Received: 01/06/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2010
• 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: 00001 MO