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

Model Number 200

Device Problem Calcified (1077)

Patient Problems Chest Tightness/Pressure (2463); Cusp Tear (2656)

Event Date 01/06/2014

Event Type  Injury  

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.The device was not returned for analysis.The reported issues could not be confirmed.Based on historical data, stent fractures and/or calcification and/ or cuspal tears can lead to stenosis, valve insufficiency and high gradients.Without the return of the devices, a conclusive root cause cannot be determined.(b)(4).

Event Description

Medtronic received information that 30 months post implant of this transcatheter bioprosthetic valve ((b)(4)) and 9 years post implant of this pulmonary valved conduit ((b)(4)), the patient presented with chest pain moderate right ventricular outflow tract obstruction, possibly due to fractured stent, stenosis, insufficiency of the valve, and calcification, cuspal tear of the valved conduit.The patient had a peak gradient of 62 mmhg and a mean gradient of 34 mmhg.Physician made the decision to explant the valve and the valved conduit.The valved conduit was taken out in fragments.The valve was successfully replaced with another manufacturers device.The devices were discarded by the hospital and will not be returned for analysis.No further adverse patient effects were reported and the patient is reported to be in stable condition.

Manufacturer Narrative

Product analysis: the device will not be returned for analysis.The customer discarded the device at the hospital.Conclusion: the device history review and investigation is in progress and when the review is complete a supplemental report will be submitted.(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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3605686
• MDR Text Key: 16285025
• Report Number: 2025587-2014-00015
• 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,Followup
• Report Date: 02/27/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2006
• Device Model Number: 200
• Device Catalogue Number: 200H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 02/04/2014
• Supplement Dates Manufacturer Received: Not provided; 02/27/2014
• Supplement Dates FDA Received: 02/28/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2003
• 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: 00017 YR