MAUDE Adverse Event Report: MEDTRONIC, INC. HALL EASY FIT; HEART-VALVE, MECHANICAL

Model Number M7700-33

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abscess (1690); Endocarditis (1834); Septic Shock (2068); No Information (3190)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device analysis.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that twenty seven years, two months post implant of this mechanical valve, this device was explanted and replaced with a bioprosthetic valve.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received information that this device was replaced due to endocarditis.Along with the endocarditis, the patient was extremely sick, including septic shock, and a possible aortic abscess.The patient initially did well post-operatively.However, the patient has subsequently been readmitted for an aortic valve replacement procedure.Patient weight added.Patient's relevant medical history added.Patient codes updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: the occurrence of endocarditis was greater than 12 months post implant (over 27 years).Based on the descriptive comments outlined from the journal literature, complaints which occurred greater than 12 months post implant were largely considered to be community acquired (refer to note 1).Therefore, it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.Also, a dhr review is not required as the valve has been implanted for over 27 years, it¿s very unlikely that the endocarditis is due to any potential manufacturing issue.No formal investigation is recommended.Without the return of the valve, a conclusive cause of the event was unable to be determined.Endocarditis related risks are addressed in the current risk management file.Medtronic will continue to monitor field performance for similar events should they occur.Note 1 - mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.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, 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: 6668744
• MDR Text Key: 78441307
• Report Number: 3008592544-2017-00037
• 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,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M7700-33
• Device Catalogue Number: M7700-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• 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: 61 YR
• Patient Weight: 45