MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505

Device Problem Perivalvular Leak (1457)

Patient Problem Aneurysm (1708)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that immediately post implant of this mechanical valve, this valve was explanted and replaced due to paravalvular leak (pvl) observed after operation.The physician described that there was an aneurysm in the left ventricle just under the mitral annulus, so it was sutured with a patch for reinforcement.However, this valve overlapped where the patch was applied.A different valve was implanted and no other adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the was evidence of blood contact.Suture holes from the surgeon¿s suture placement could not be confirmed.There were no sutures returned with the valve.The leaflets were in the closed position.The leaflets were intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.The leaflets were fixed in the closed position due to the presence of dried blood.The carbon subassembly was unable to rotate in the sewing ring due to the presence of dried blood.The device was rinsed and cleaned under water.Post cleaning, the device leaflets and carbon subassembly could move freely.The sewing ring was removed by systematically undoing the stitching to expose the stiffening ring window.The lock wire was pulled out and the stiffening ring was removed from the orifice.Conclusion: based on the information received and the product analysis, the paravalvular leak (pvl) was not due to the valve related issue.The analysis confirmed that the device was within specification and deemed acceptable.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6423329
• MDR Text Key: 70514888
• Report Number: 3008592544-2017-00011
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2020
• Device Model Number: 505
• Device Catalogue Number: 505DM26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention