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

Model Number 500DM25

Device Problem Structural Problem (2506)

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

Event Date 02/04/2015

Event Type  Injury  

Event Description

Medtronic received information that immediately following implant of this mechanical valve, the valve leaflet was difficult to move.The valve was explanted and replaced with an alternative medtronic mechanical valve of the same size.It was reported that no abn ormalities were noticed on the valve pre-implant.No adverse patient effects were reported.

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, after the carbon subassembly was cleaned and dried, the leaflets were fully mobile.During sewing ring examination, a cut stitch was noted on the sewing cuff flange.It was determined that the suture was cut during implant.The stitching and back-stitching of the sewing ring met specification.No as-manufactured surface finish anomalies were identified.The as-returned dimensions for the orifice met engineering drawing specification.The as-returned dimensions for the left leaflet met engineering drawing specification.The as-returned dimensions for the right leaflet met engineering drawing specification.The crown to notch (c-n) gap was measured; the as-returned gap for the left and right leaflets were within the engineering drawing specification.A continuous scan cmm was used to assess the roundness of the stiffening ring.The difference between the minimum circumscribed and maximum inscribed stiffening ring dimensions was within the engineering drawing specification.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 conclusive cause of the reported event could not be determined as the device met specification.Based on the product analysis, the complaint could not be confirmed and no evidence of a leaflet motion issue was noted.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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; 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: 4565139
• MDR Text Key: 5550744
• Report Number: 3008592544-2015-00007
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: 500DM25
• Device Catalogue Number: 500DM25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2014
• 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: 00061 YR