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

Model Number A7700

Device Problem Incomplete Coaptation (2507)

Patient Problems Host-Tissue Reaction (1297); Nausea (1970); Pain (1994); Low Cardiac Output (2501)

Event Date 09/01/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: medtronic hall valve malfunction due to pannus formation in the aortic position with peculiar movement of the leaflet: a case report citation: the journal of heart valve disease 2008;17:583-585 authors: masahide horiguchi, tetsuya seko, takahiro yazu, masaki takeuchi, takehiko ichikawa the approximate date of publish used for event date.

Event Description

Medtronic received information via literature review that a (b)(6) female patient underwent a successful aortic valve replacement with implant of a medtronic 22-mm prosthetic valve (serial not reported).Approximately twelve years postoperative the patient presented to the author's institution with epigastric pain and nausea.After hospitalization, the patient presented with a sudden precipitous deterioration of hemodynamics for a period of about ten minutes.Cardiac catheterization revealed normal coronary arteries and cardiac filling pressures.Fluoroscopy showed a transient insufficiency of the prosthetic valve closure with the opening angle of 70° and the closing angle of 30° the patient was referred for urgent surgery.Intraoperative findings included pannus at the left ventricular aspect of the prosthetic valve extending into the orifice which directly restricted leaflet movement in the closing phase.The leaflet movement showed no consistent pattern as both normal movement and half-closing occurred regularly resulting in alternating phases of normal hemodynamics and low output syndrome.The prosthetic valve was explanted and replaced by a new non-medtronic prosthetic valve, and the patient was discharged without further complications.Additional information has been requested.

Manufacturer Narrative

Conclusion: no device was returned and no unique device identifier numbers were provided.Based on the available information a review of the device history record could not be performed and root cause could not be identified.

Event Description

Requests for additional information provided no further details.

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 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: 5108894
• MDR Text Key: 26938023
• Report Number: 2025587-2015-01025
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• 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: 09/30/2015
• 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: 00063 YR