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

Model Number	9-TVLPC4F90/080
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Arrhythmia (1721); Pericardial Effusion (3271); Heart Block (4444)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11607829
• Report Number: 2135147-2021-00120
• Device Sequence Number: 3280535
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER PICCOLO OCCLUDER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 DA
• Patient Weight: 1