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

Model Number M7700

Device Problem Mechanical Jam (2983)

Patient Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 02/01/1988

Event Type  Death  

Manufacturer Narrative

Citation: masters rg, et al.Extrinsic obstruction of the medtronic-hall disk valve in the mitral position.Ann thorac surg.1988 fe b;45(2):210-2.Doi: 10.1016/s0003-4975(10)62440-x.Earliest date of publish used for date of event and date of death: february 1, 1988 (month and year valid).No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding three cases of extrinsic obstruction of the medtronic-hall prosthesis in the mitral position.Patient 1: a (b)(6) female patient who underwent mitral valve replacement with a 29 mm medtronic-hall mechanical valve using an interrupted mattress suture technique of ethibond buttressed with teflon pledgets.The valve seated well, with free movement of the disk occluder.The patient was weaned from cardiopulmonary bypass without difficulty.However, during closure of the sternotomy, hypotension occurred with electromechanical dissociation, necessitating reinstitution of cardiopulmonary bypass.The left atrium was re-opened, and the disk occluder was found to be firmly stuck in the closed position.One suture had torn through the friable anterolateral mitral annulus and was overhanging and had become lodged between the valve ring and disk, jamming the valve in the closed position.The disk was released manually, and the valve was re-sutured with considerable difficulty.Despite intra-aortic balloon counter-pulsation and dopamine therapy, the patient could not be weaned from cardiopulmonary bypass.The authors did not explicitly state the patient¿s outcome, but based on the given circumstances, it is likely the patient died.Patient 2: a (b)(6) female patient who underwent mitral valve replacement with a 29 mm medtronic-hall mechanical valve.Although the valve disk moved freely, during closure a sudden drop in blood pressure occurred with electromechanical dissociation.The left atrium became noticeably distended.Cardiopulmonary bypass was reinitiated, and the atrium was re-opened.The tip of the posteromedial papillary muscle was wedged between the disk and valve ring, locking the valve in the closed position.The valve was opened manually, and the papillary muscle was debrided.The patient was weaned from cardiopulmonary bypass without difficulty and was discharged twelve days later.Patient 3: a (b)(6) female patient who underwent mitral valve replacement with a 31 mm medtronic-hall mechanical valve.The valve disk was seen to move freely, and the patient was weaned from cardiopulmonary bypass without difficulty.During closure of the sternotomy, recurrent episodes of electromechanical dissociation were noted.With a normal electrocardiogram, there were recurrent episodes of cessation of left ventricular ejection followed by spontaneous recovery.Cardiopulmonary bypass was reinitiated, and the atrium was opened.The tip of the posteromedial papillary muscle was found to lay on the valve ring, causing intermittent locking of the disk against the ring.The papillary muscle was debrided, resulting in a normally functioning valve.The patient was weaned from cardiopulmonary bypass and was subsequently discharged after an uneventful hospital course.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13026563
• MDR Text Key: 282404142
• Report Number: 2025587-2021-03770
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• 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; Life Threatening; Death
• Patient Age: 62 YR
• Patient Sex: Female