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

Model Number 505DA18

Device Problem Entrapment of Device (1212)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/07/2015

Event Type  Injury  

Event Description

Medtronic received information that post implant of this mechanical aortic valve, the orifice of left coronary artery was blocked and a leaflet of this valve was immobilized by the heart tissue.This valve was explanted and a different valve was implanted.The procedure was completed successfully with no adverse patient effects reported.

Manufacturer Narrative

The product is being forwarded to medtronic's laboratory for evaluation.At this time no definitive conclusion can be made regarding the clinical observation.Patient weight was not provided to medtronic.(b)(4).

Manufacturer Narrative

Additional information was received from the implanting physician that the blockage of the left coronary artery may have been due to the patient's physiology.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was received detached from the valve holder.Two unknown components were received with the valve and valve holder.The valve was discolored, showing evidence of blood contact.Both valve leaflets were intact.After the carbon subassembly was cleaned and dried, the leaflets were fully mobile.The tissue annulus diameter of the valve was measured within specification.During sewing cuff examination, the cuff met specifications.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 reported issue of the coronary artery being blocked could not confirmed.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 serial number was verified to be correct.A conclusive cause of the reported immobile leaflet could not be determined as the device met specification.Based on the analysis, the complaint could not be confirmed and no evidence of a leaflet motion issue was noted.

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: 4730837
• MDR Text Key: 5705246
• Report Number: 3008592544-2015-00013
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Device Lot Number: 618901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 04/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/17/2015
• Supplement Dates FDA Received: 05/18/2015; 06/25/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2013
• 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
• Patient Age: 00076 YR