MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MASTERS MHV

Device Problems Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The abstract, "catheter ablation autumn conference 2022" was reviewed.It was reported that on an unknown date, a 29mm unknown mechanical heart valve was implanted into a patient with mitral valvular regurgitation along with a maze procedure concomitantly.After the valve was implanted, re-entry was done for ablation for atrial tachycardia.While mapping using a pentaray mapping catheter, one of the spines of the catheter got caught between the leaflets resulting in the spine cover becoming fractured.The leaflets of the valve became immobilized.The patient was noted to have remained hemodynamically stable.To resolve the situation, the mapping catheter was used to push the leaflets on the valve, which resolved the stuck leaflets.The wire that was caught between the leaflets became completely broken, and embolized into the left circumflex artery.The embolized wire was removed from patient anatomy by transcatheter snare.No additional information was provided.

Manufacturer Narrative

An event of leaflet immobility was reported.Information from the field indicated that a mapping catheter was used to ablate atrial tachycardia.One of the spines of the catheter got caught between the leaflets, resulting in immobilizing the leaflets.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the mapping catheter which was used post-procedure has contributed to the reported incident.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16525149
• MDR Text Key: 311126680
• Report Number: 2135147-2023-01130
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MASTERS MHV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Female