MAUDE Adverse Event Report: ABBOTT AVEIR¿ DELIVERY CATHETER; LEADLESS PACEMAKER

Model Number	LSCD111
Medical Device Problem Codes	Activation Failure (3270); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported events of delivery catheter unable to go into tether mode and spontaneous release were confirmed.As received, a catheter was returned in one piece without the device attached.The tether control knob was in the aligned position, and the tether mode control was in dock mode but the distal tether wires were returned partially extended and the tether bullets were slightly misaligned.X-ray examination found both tether wires fractured and buckled at the transition zone.The cause of the reported events was isolated to the fractured and buckled tether wires at the transition zone.
Event or Problem Description
It was reported that during the initial implant procedure, after fixation of the right ventricle (rv) leadless pacemaker (lp), the delivery catheter was unable to go into tether mode.During attempts to enter tether mode, spontaneous release of the fixated rv lp occurred.The rv lp was explanted and replaced using a new delivery catheter.The patient was in stable condition.

• Brand Name: AVEIR¿ DELIVERY CATHETER
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24382457
• Report Number: 2017865-2026-02089
• Device Sequence Number: 13313995
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)10933185(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 10933185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown