MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD111
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Date of Event	08/07/2026
Type of Reportable Event	Death
Event or Problem Description
During implant procedure, following the deflection test the right ventricular (rv) leadless pacemaker (lp) was not able to be separated from the catheter.Troubleshooting methods were performed in situ to release the rv lp but were unsuccessful.The catheter and rv lp were removed from the patient and force was applied to the catheter and rv lp and the rv lp was successfully released.The catheter and rv lp were not used and replaced to continue the procedure.During the next attempt to implant the replacement rv lp the patient experienced a decrease in blood pressure.Ultrasound imaging was performed which confirmed peritoneal bleeding.The patient was administered catecholamines to address the bleeding but this was not successful.The patient died during the procedure.A dissection or rupture was alleged.A new lp and delivery catheter was selected for implant.During positioning the patient experienced a decreased in blood pressure.An ultrasound was performed, however, no anomalies were observed.Catecholamines were administrated but did not stabilize the patient.A second ultrasounds was performed and abdominal bleeding was observed.Due to the patient¿s do not resuscitate order, no additional intervention was performed and the patient passed away.The physician did not allege a malfunction on the products.The suspected the cause of the bleeding was due to a rupture of the femoral vein.

• Brand Name: Aveir¿ Delivery Catheter
• Common Device Name: Leadless Pacemaker
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50229722
• Report Number: 2017865-2026-16848
• Device Sequence Number: 10273672
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)11300264(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 11300264
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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: Death
• Patient Sex: Unknown