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

Model Number 505DA

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: product analysis is in progress.When analysis results are complete, a supplemental report will be submitted.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.

Event Description

Medtronic received information during the implant of this 20 mm mechanical valve, when stitching the valve while tying the suture line knot, a laceration on the aortic wall occurred.The valve was explanted and an 18 mm mechanical valve was implanted with no further adverse patient effects reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the valve was slightly discolored showing evidence of blood contact.The serial number was verified to be correct.There were no surgeon¿s sutures returned with the valve and suture holes from the surgeon¿s suture placement could not be confirmed.Both leaflets were in the closed position and no evidence of damage such as cracks and/or surface anomalies were noted.Both inflow and outflow valve hinge mechanisms were intact with no evidence of damage.Using an actuator to test leaflet movement, the leaflets moved without difficulty.It was verified that the carbon subassembly rotated in the sewing ring.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.Based on the results of the analysis, the device is considered acceptable.Based on the reported information, the cause of the laceration on the aortic wall could potentially be due to technical error related to sizing or implant technique.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, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6773992
• MDR Text Key: 82051918
• Report Number: 3008592544-2017-00042
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: 505DA
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2016
• 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: 59 YR