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

Model Number M7700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Following explant, the device was cleaned and presented to the patient by the hospital staff; the device will not be returned to medtronic for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that twenty five years, two months post implant of this mechanical valve, this valve was explanted and replaced with a bioprosthetic valve because of the patient's chronic anti-coagulation treatment and recurring subdural hematomas.The patient had two spontaneous intercranial hemorrhages in the year prior to this replacement procedure.For that reason, it was requested that the patient have the mechanical valve replaced with a tissue valve.The has reported no post-operative complications, and no other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.With the limited received information, there was no allegation that the device caused the re-operation.Based on the received information, the cause of the re-operation was due to the patient condition.

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: 6071413
• MDR Text Key: 58916556
• Report Number: 2025587-2016-01711
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M7700
• Device Catalogue Number: M7700-33MH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Weight: 67