MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HALL EASY FIT; HEART-VALVE, MECHANICAL

Model Number A7700

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem Death (1802)

Event Date 10/27/2015

Event Type  Death  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that 9 years 8 months post implant of this 22mm aortic mechanical valve, the valve leaflet became dys functional during a heart catheterization procedure due to impingement caused by a broken frame/strut of the valve.Subsequently, the patient died.The physician stated the cause of death was a malfunction of the artificial aortic valve.No autopsy was performed, and the valve remains in the patient.

Manufacturer Narrative

Conclusion: the device instructions for use (ifu) states ¿do not pass a catheter, surgical instrument, or transvenous pacing lead through the prosthesis as this may cause valvular insufficiency, leaflet damage, leaflet dislodgement, and/or catheter/instrument/lead entrapment.¿ it also states ¿valve dysfunction due to occluder impingement of any mechanical heart valve, whether caused by improper sizing, improper orientation, tissue interference, anatomical interference, suture interference, catheterization, or any other cause, may result in severe complications including patient death.¿ without the return of the device, a conclusive root cause of the valve damage (broken frame/strut) cannot be determined.The reported information did not indicate a potential manufacturing issue.Based on the received information, the broken frame/strut of the mechanical valve mostly likely was caused by the catheterization procedure and led to the patient death.There are no suggested deficiencies related to product quality/performance or manufacturing processes.

Manufacturer Narrative

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

• Brand Name: HALL EASY FIT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• 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: 5242665
• MDR Text Key: 31823877
• Report Number: 2025587-2015-01212
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Model Number: A7700
• Device Catalogue Number: A7700E22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2005
• 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
• Patient Age: 00085 YR
• Patient Weight: 76