MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505

Device Problem Unraveled Material (1664)

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

Event Date 06/02/2015

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this mechanical valve, when the surgeon started to suture the valve (13-14 sutures in the patient's annulus and 7-8 in the valve cuff), the suture ring began to unravel.The physician decided not to implant the valve.Another valve was successfully implanted in the patient with no adverse patient effects reported.

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions can 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, visual inspection of the device determined that it was clean, showing no evidence of blood contact.Two broken stitches were observed along the outflow rail which caused the sewing cuff flange to open up.The stitching and back stitching were determined to be within specifications.

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.The analysis of the returned valve confirmed the sewing cuff has a broken stitch.Additional analysis of the sewing ring noted that all of the other stitching and back stitching met manufacturing specification.Although a conclusive cause of the issue cannot be determined, additional information indicated that the physician placed the sutures in the inner ½ of the sewing cuff.Per the open pivot instruction of use (ifu) for implanting this heart valve: ¿deep needle placement will contact the strengthening band inside the sewing cuff, impeding the smooth placement of sutures.Sutures should be placed in the outer 1/3 of the cuff.".

Manufacturer Narrative

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

• Brand Name: AORTIC AP
• 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: 4872163
• MDR Text Key: 5863199
• Report Number: 3008592544-2015-00025
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 505
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2014
• 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