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

Model Number 500DM

Device Problem Incomplete Coaptation (2507)

Patient Problem No Code Available (3191)

Event Date 04/17/2014

Event Type  Injury  

Event Description

Medtronic received information that after the implant of this mechanical valve, the leaflets did not open properly, determined manually by finger and then on echocardiogram.There was no sub-valvular tissue noted to be interfering.The valve was explanted and replaced with the same size valve.No adverse patient effects were reported.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.Device history review and investigation is still in process, once the review and investigation is complete 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.A conclusive cause of the reported leaflet motion issue could not be determined as the valve was not returned for analysis.A supplemental report will be filed if the device is returned for analysis.

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, INC.; 3800 annapolis lane north; minneapolis MN 55447
• 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: 3807811
• MDR Text Key: 4477478
• Report Number: 2134151-2014-00023
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2018
• Device Model Number: 500DM
• Device Catalogue Number: 500DM25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2013
• 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