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

Model Number 505

Device Problem Gradient Increase (1270)

Patient Problem Regurgitation, Valvular (2335)

Event Date 04/16/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was discolored showing evidence of blood contact.The valve leaflets were intact.After the carbon subassembly was cleaned and dried, the leaflets were fully mobile.The tissue annulus diameter was within specification.During sewing ring examination, the sewing cuff met specification for stitching and back-stitching.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 difference between the minimum circumscribed and maximum inscribed stiffening ring dimensions was within the engineering drawing specification.The complaint could not be confirmed.

Event Description

Medtronic received information that during the implant of this mechanical valve, the physician sutured in the device and during the ultrasound, results showed poor blood flow dynamics and valvular regurgitation.The physician removed this valve and implanted a different valve.No adverse patient effects were reported.

Manufacturer Narrative

Requests for patient information have been unsuccessful.The device has been returned for analysis.The analysis and investigation are in progress.A supplemental report will be filed upon completion of the analysis and investigation.(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.The root cause for the reported clinical observation could not be determined as the valve was inspected and tested and no anomalies were found.

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: 4811757
• MDR Text Key: 13499931
• Report Number: 3008592544-2015-00016
• 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: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Model Number: 505
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2013
• 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