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

Model Number 502AG27

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Endocarditis (1834); Left Ventricular Dysfunction (1947)

Event Date 12/20/2017

Event Type  Death  

Manufacturer Narrative

The product has been returned and continues to undergo analysis.At the completion of the analysis a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 9 months post implant of a non-medtronic prosthetic valve, due to endocarditis, multiple vegetat ions and an abscess, the valve was explanted.Prior to the implant of this 27 mm mechanical valved graft, visual inspection noted the valve was intact.During the implant, the physician noted that one of the leaflets had detached and was in the ventricular cavity.The device was removed and replaced with a 23 mm valved graft.Later that day, the patient died of severe ventricular dysfunction.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed one of the leaflets was not returned.The valve was received with one leaflet attached.The sewing ring was damaged, and the graft was not returned.The stiffening ring was completely exposed.The existing sewing ring was slightly discolored showing evidence of blood contact.The attached leaflet was received in closed position and was intact with no evidence of damage such as cracks and/or surface anomalies.The attached leaflet moved to open and closed position without difficulties.Both inflow and outflow valve hinge mechanisms were intact.Damage to the carbon was noted.Fine cracks were observed on the rim at the inflow aspect and cracks and missing carbon pieces were observed on the rim at the outflow aspect.Using a lab blue actuator to test leaflet movement, the one leaflet moved without difficulty.The lock wire was pulled out and the stiffening ring removed from the orifice.A piece of the carbon broke off (the piece between the observed cracks).The serial number was verified.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that the valve portion of the valved graft was removed and the graft was left in place.The physician subsequently replaced and sewed a 23 mm medtronic mechanical valve to the existing graft.The physician reported that the that the death was due to the patient's other comorbidities and not related to the valve or its function nor was there any allegation that the valve contributed to the patient's death.Added patient initials.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC VALVE GRAFT
• 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: 7185453
• MDR Text Key: 97069179
• Report Number: 3008592544-2018-00003
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: 502AG27
• Device Catalogue Number: 502AG27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• 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): Death; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 75