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

Model Number 9-TVLPC4F90/080

Device Problem Biocompatibility (2886)

Patient Problems Arrhythmia (1721); Pericardial Effusion (3271); Heart Block (4444)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing reference number: (b)(4).On (b)(6), 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a 22 day old, 780g patient with the following patent ductus arteriosus(pda) dimensions: minimal diameter of 2.4mm, diameter at aortic ampulla of 3.4mm and pda length of 6mm.Using an amplatzer torqvue lp catheter the device was placed intraductal and it was noticed via echo and fluoroscopy that the device was oversized.The physician recaptured the device prior to release from the delivery cable and removed it from the patient.A 3/2mm amplatzer piccolo occluder was then selected for implant.The 3/2mm device was implanted intraductal and appeared to be the correct size for closure, as it appeared to sit well.After careful consideration the physician was satisfied with the device placement and released the 3/2mm amplatzer piccolo occluder in the pda.The physician then proceeded to perform a final angiogram to confirm placement after release.Angiogram showed a pericardial effusion in the patient.The patient then went into complete heart block.The patient was treated with atropine and epinephrine.The patient was then carefully observed and noted to go into second degree heart block and after more observation the patient went into bigeminy.After some time the patient reverted back into sinuous rhythm.A final angiogram was repeated and confirmed correct placement of the device and only a trivial effusion was remaining on fluoroscopy.There was a reported clinically significant delay in the procedure.The 3/2mm device remains implanted and the patient will be carefully monitored and a follow up echo will be performed.The patient is currently stable.The physician believes the injury may have occurred due to the delivery cable or catheter.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10.An event of pericardial effusion and heart block was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE LP CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11607829
• MDR Text Key: 249447244
• Report Number: 2135147-2021-00120
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (y/n): N
• PMA/PMN Number: K162228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 9-TVLPC4F90/080
• Device Catalogue Number: 9-TVLPC4F90/080
• Device Lot Number: 7565005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER PICCOLO OCCLUDER
• Patient Outcome(s): Required Intervention
• Patient Age: 22 DA
• Patient Weight: 1