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

Model Number A7700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Date 07/01/2004

Event Type  Injury  

Manufacturer Narrative

Citation: ruel et al.Late incidence and determinants of stroke after aortic and mitral valve replacement.Ann thorac surg.2004 jul ;78(1):77-83; discussion 83-4.Doi: 10.1016/j.Athoracsur.2003.12.058.Earliest date of publish used for date of event.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 late incidence and determinants of stroke after aortic and mitral valve replacement.All data were collected from a single center between 1970 and 2002.The overall study population included 3,189 patients (predominantly male, mean age 61.41 years).Among these patients, 1,546 were implanted with a medtronic hall mechanical valve (n=620) or a medtronic hancock i (n=221), hancock ii (n=577), or intact (n=128) bioprosthetic valve.No unique device identifier numbers were provided.Among all patients, 97 deaths occurred due to stroke as a primary cause.No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: stroke with neurologic deficit lasting more than three weeks, major bleeding events requiring hospital admission or transfusion.Based on the available information medtronic product may have been associated with the adverse event(s).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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11992798
• MDR Text Key: 255990277
• Report Number: 2025587-2021-01877
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• 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: 06/07/2021
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR