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

Model Number A7700

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 10.5 years after implant, the patient with this mechanical heart valve presented for a follow-up visit and exhibited neurological symptoms despite good anticoagulation.Vascular reasons for the symptoms were eliminated.The observed symptoms were amaurosis fugax (cerebral insult left parietal side, present since valve implantation) and a recent acute one-hour episode of amnesic aphasia.It also was reported there had been bubble production at the valve (cavitation) since device implant.The bubbles appear at the posterolateral valve ring and the bubble production increases with dobutamin intake.The physician suspected valve-related cavitation was occurring.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.Additional investigation is pending; a supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Cine images were requested but were not available for review.From the available information, a conclusive cause of the suspected cavitation could not be determined.Per consultation with medtronic technical services, cavitation occurring with mechanical valves is documented in literature.This phenomenon causes microbubble formation which is suspected of having a strong pro-coagulant effect.The result can increase the incidence of cerebral-embolic events.The predicted occurrence is estimated as highly unlikely.A review of the complaint database showed that there have been no similar incident reports received.

Manufacturer Narrative

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

• Brand Name: MEDTRONIC HALL PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east 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: 3721685
• MDR Text Key: 4232190
• Report Number: 2025587-2014-00179
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700
• Device Catalogue Number: A7700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• 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): Other
• Patient Age: 00065 YR