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

Model Number A7700E

Device Problem Gradient Increase (1270)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received in a clear solution in a specimen jar.The valve was discolored showing evidence of blood contact.The carbon component showed traces of biological material.Two remnants of native tissue were received with the valve.Two remnants of host tissue were received with the valve for analysis.Tears were observed on the sewing ring.A remnant of a green multifilament suture remained attached to the valve.The disc appeared intact with no visible evidence of damage such as cracks and/or surface anomalies.The disc rotated without difficulty.The disc moved to fully open and close under its own weight.The housing appeared intact with no visible evidence of damage.A remnant of glistening off white pannus remained attached to the sewing ring on the outflow extending slightly over the outflow orifice.A trace of pannus was observed on the inflow.Two remnants of pannus were received with the valve.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed no evidence of mineralization in the valve and/or host tissue.Radiography showed no evidence of fractures in the housing.Conclusion: investigation results indicated that a conclusive cause of the reported event could not be determined.However, pannus was observed on sewing ring/outflow and inflow.Also an unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Pannus overgrowth would have impaired the leaflet mobility.The impairment of leaflet mobility may have led to the high gradient.

Event Description

Medtronic received information that eleven years, ten months post implant of this mechanical valve, the gradients across the valve measured 40mmhg, and the patient was symptomatic upon exertion.The echocardiogram showed the valve leaflets appeared to be moving without obstruction.Mean gradients were measured by tte six years post-implant at 36 mmhg; peak gradients were measured at 64 mmhg.Peak gradients were measured by tte twelve years post-implant at 90 mmhg, and mean gradients were measured at 54 mmhg.The patient presented with aortic stenosis, but no definitive cause of the elevated gradients was ascertained.This valve was explanted approximately twelve years, one month post-implant and was replaced with a non-medtronic bioprosthetic valve.No other adverse patient effects were reported.

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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5582857
• MDR Text Key: 42850073
• Report Number: 2025587-2016-00520
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2006
• Device Model Number: A7700E
• Device Catalogue Number: A7700E23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• 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: 00061 YR
• Patient Weight: 96