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

Model Number M7700

Device Problems Partial Blockage (1065); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Mitral Valve Stenosis (1965); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

Citation: mantri n.; et al.¿obstruction alternans¿: a rare doppler echocardiographic sign of severe, prosthetic stenosis.J am coll cardiol.2020 mar, 75 (11_supplement_1) 3154.Https://www.Jacc.Org/doi/abs/10.1016/s0735-1097(20)33781-5.Presentation date: sunday, march 29, 2020.Earliest date of publication used for date of event.Medtronic products referenced: med hall easy-fit mechanical mitral valve (pma# p790018, product code: lwq) earliest approved product used for product code and pma#.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 via literature regarding a (b)(6) year-old female patient with a history of rheumatic heart disease who underwent implant of a 29-mm medtronic med-hall mechanical mitral valve and tricuspid valve annuloplasty ring at age 29 years (unique device identifier numbers not provided).The patient was hospitalized with heart failure.A heart auscultation phonocardiogram was abnormal and doppler echocardiography indicated a case of obstruction alternans.The patient underwent surgical valve replacement using a non-medtronic mechanical mitral valve prosthesis.Pathological examination of the explanted valve indicated circumferential pannus formation, which was noted to have led to obstruction of leaflet motion, causing severe mitral stenosis.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13946004
• MDR Text Key: 288173892
• Report Number: 2025587-2022-00838
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M7700
• Device Catalogue Number: M7700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• 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
• Treatment: UNKNOWN TRICUSPID ANNULOPLASTY RING
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female