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

Model Number	LSCD111
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the initial implant procedure, the right ventricle (rv) leadless pacemaker (lp) was difficult to dock to the delivery catheter.After fixation and release, the lp became lodged horizontally in the tricuspid valve.Multiple attempts to retrieve the lp were made due to difficulty attaching it to the retrieval catheter.When retrieving the rv lp with the retrieval catheter, the rv lp prematurely separated from the retrieval catheter and dislodged to the right atrium.The rv lp was able to be retrieved and replaced to resolve the event.The prolongation of the procedure was clinically significant.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of difficulty docking was not confirmed.As received, a catheter was returned in one piece without the device attached.Visual and x-ray examinations of the catheter did not find any anomalies with the exception of procedural damage.Dimensional analysis was performed and found all measurements that were taken met device specification.The associated device was able to load and release without any difficulty.

• 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: 24471864
• Report Number: 2017865-2026-03409
• Device Sequence Number: 15856880
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)11067314(17)261130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 11067314
• Was Device Available for Evaluation?: No
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown