MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

Model Number LSP112V

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Stroke/CVA (1770); Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Event Description

Related manufacturer reference number: (b)(4).It was reported aveir leadless pacemakers (lp) were used as part of a study involving aveir and micra leadless pacemakers.This event it to report the observations on the aveir lps used in the study.The study reviewed twenty-five consecutive patients who received aveir lps between may and november 2022 from implant to ten weeks post-implant.During one implant attempt, the aveir lp had difficulty releasing from the delivery catheter which resulted in dislodgement and increased capture thresholds.The aveir lp was successfully retrieved and repositioned.The study discussed the safety of aveir lps, referencing the aveir vr trials.The reference cited pericardial effusion and cardiac tamponade were the commonest complications with an incidence between 0.3% and 1%.Some of these patients needed sternotomy and 1 patient died in these trials.Vascular access complications, pericarditis, stroke, pulmonary embolism, and contrast nephropathy have been reported with incidence <0.3% and device dislodgement with reimplantation happened in 1.5% of implants in these trials.The study stated, of these complications, only the one case of dislodgement occurred within the twenty-five implants of the study but was hesitant to draw any inferences on safety due to the difference in sample size and short term follow-up limits.The study concluded that aveir lps were similar in effectiveness and safety compared to micra.

Manufacturer Narrative

Section e: wiley title: a comparative study of the two leadless pacemakers in clinical practice.(j cardiovasc electrophysiol.2023;34:1896-1903.Doi:10.1111/jce.16019 ) authors: ghanshyam shantha md, mph; jonathan brock md; matthew j.Singleton md, mbe, mhs, msc; alexander joseph schmitt md; patrick kozak md; george bodziock md; natalie bradford md; patrick whalen md; prashant bhave md.

• Brand Name: AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
• Type of Device: Leadless pacemaker
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19001310
• MDR Text Key: 338874435
• Report Number: 2017865-2024-37174
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSP112V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• 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): Death