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

Model Number 500DM25

Device Problem Material Rupture (1546)

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

Event Date 03/25/2015

Event Type  Injury  

Event Description

Medtronic received information that during implant of this mechanical valve, the physician found the suture ring was ruptured.The valve was explanted.No adverse patient effects were reported.The device will be returned for analysis.

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

Correction: the device serial number was incorrectly entered as a lot number on the initial report.This number has been moved to the serial number field on this report.Product analysis: upon receipt at medtronic's quality laboratory, the subassembly was cleaned and dried, and the leaflets were fully mobile.The tissue annulus diameter of the valve was measured and found to be within specification.During sewing ring examination, a broken suture was noted.All other stitching and back-stitching 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 engineering drawing specification.The roundness of the stiffening ring was assessed; the difference between the minimum circumscribed and maximum inscribed stiffening ring dimensions was within the engineering drawing specification.The complaint was confirmed, as product analysis found that the sewing cuff had a broken stitch.The investigation is ongoing - a supplemental report will be filed upon the completion of the investigation.

Manufacturer Narrative

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.Although a conclusive cause of the cut cannot be determined, it appears that the stitch had come in contact with a sharp instrument, possibly during the procedure.The instructions for use for the open pivot mechanical heart valve has a warning that states ¿when securing the valve in place, suture needles should be passed through the outer half of the sewing cuff and suture ends should be cut short after the knots are tied.It is suggested that only taper point needles be used for suturing the cuff as taper cut or other cutting needles may cut the cuff fibers.¿.

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; 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: 4708024
• MDR Text Key: 5725271
• Report Number: 3008592544-2015-00011
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Model Number: 500DM25
• Device Catalogue Number: 500DM25
• Device Lot Number: 677705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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: 00054 YR