MAUDE Adverse Event Report: ABBOTT AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

Model Number LSP112V

Device Problems Failure to Capture (1081); Stretched (1601); Device Dislodged or Dislocated (2923)

Patient Problem Embolism/Embolus (4438)

Event Date 04/11/2024

Event Type  Injury  

Event Description

It was reported that loss of capture was observed on the ventricular device after the implant procedure was completed.An x-ray was performed and the device dislodged to the groin vein.The device was explanted and replaced to resolve the event and the patient was in stable condition.Following the explant procedure, the helix was observed to be stretched.

Manufacturer Narrative

Reported event of stretched helix was confirmed.Reported event of failure to capture and dislocated device were not confirmed.A visual inspection of the device revealed the helix was stretched and bent out of specification.The helix elongation is consistent with having occurred during implant procedure.Further analysis performed, including output verification revealed no anomalies contributing to reported event of capture problem.A longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
• Type of Device: LEADLESS PACEMAKER
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19167294
• MDR Text Key: 340869745
• Report Number: 2017865-2024-39435
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 05415067034472
• UDI-Public: (01)05415067034472(10)S000093696(17)250227
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P150035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP112V
• Device Lot Number: S000093696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2024
• 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