MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE LP; CATHETER, PERCUTANEOUS

Catalog Number UNK AMPLATZER TORQVUE LP

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled ¿transcatheter closure of patent ductus arteriosus in preterm infants: results from a single-center cohort".

Event Description

The article, "transcatheter closure of patent ductus arteriosus in preterm infants: results from a single-center cohort", was reviewed.The article presented a case study of a 30-day-old,1265g infant with a patent ductus arteriosus (pda).It was reported that on an unknown date, an unknown amplatzer piccolo occluder was chosen for implant with a 4f amplatzer torqvue delivery sheath.During procedure, the device was positioned in the ductus arteriosus but did not sufficiently occlude the defect.During the final attempt to deploy, it was reported the guidewire and the delivery sheath swapped their trajectory and got stuck into the right ventricle infundibulum.This led to a cardiac tamponade that was limited as long as the sheath stayed in the infundibulum.A decision was made to perform an emergency sternotomy to drain the pericardial effusion and ligate the pda.Post-procedure, the patient developed inferior vena cava (ivc) thrombosis that was treated with heparin therapy.It was noted the only symptom was an isolated macroscopic hematuria.The study concluded that transcatheter closure of a pda is a valid alternative to surgical ligation due to its high success rate and low incidence of post-ligature syndrome.Nevertheless, we also report rare, although serious complications.[(b)(6)].

Manufacturer Narrative

As reported in a research article, transcatheter closure of patent ductus arteriosus in preterm infants: results from a single-center cohort.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE LP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18711934
• MDR Text Key: 335526029
• Report Number: 2135147-2024-00681
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER TORQVUE LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• 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): Required Intervention; Life Threatening
• Patient Age: 1 MO
• Patient Weight: 1 KG