MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2013

Event Type  Injury  

Event Description

Medtronic received information that prior to implant of this 33mm mechanical valve, all native valve leaflet tissue was removed.An attempted intra annular implant was performed, with both mechanical leaflets moving normally during implant testing.However, when the patient was taken off bypass, the echocardiogram showed only one leaflet was moving.The valve was explanted, remaining impinging tissue was removed and a new 33mm non-medtronic mechanical valve was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

Analysis: the device returned has been requested, this report will be updated upon return of the product and completion of analysis.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was returned for analysis.Images of the inflow and outflow of the valve were taken.The valve was visually inspected with no as-manufactured anomalies noted.The serial number was verified to be correct.A cut was noted on the sewing cuff which appeared to be due to explant.All stitching and back-stitching met specification.The valve was cleaned and dried: the leaflets were fully mobile and the carbon subassembly rotated in the sewing ring.Inspection and functional testing of leaflet motion was performed per the current manufacturing process requirements.The as-returned orifice and leaflets were dimensionally inspected.The stiffening ring was measured for roundness.The valve met all functional and dimensional specifications.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.It is possible that impinging tissue was the cause of one leaflet not moving.The open pivot ifu has the following caution when implanting mitral valves: ¿caution: if mitral valve apparatus preservation techniques are used, it is important to check leaflet motion following valve implantation".(b)(6).

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS MEDICAL; 3905 annapolis lane north; minneapolis MN 55447
• 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: 3549622
• MDR Text Key: 4215375
• Report Number: 2134151-2014-00001
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: 500
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 01/03/2014
• Supplement Dates Manufacturer Received: Not provided; 02/26/2014
• Supplement Dates FDA Received: 02/27/2014; 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2012
• 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