MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ATV12F45/80
Medical Device Problem Codes	Material Invagination (1336); Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of bulbous shaped deformity and tip of the sheath was folded was reported.A returned device assessment could not be performed as the device was not returned for analysis.Field indicated that device was deployed and multiple attempts to recaptured during the procedure which may have contributed to the fold of the sheath.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2023, a 38mm amplatzer septal occluder was chosen for implantation into an atrial septal defect (asd) utilizing a 12f amplatzer trevisio delivery system.After positioning the right disc of the occluder, the left disc had a bulbous shaped deformity.It was decided to retrieve the device and remove from anatomy.However, the left disc would not reenter the sheath as it was in a small ball shape.After several attempts and "untwisting" the cable, the device was able to enter the sheath.When removing the sheath, the blue tip of the sheath was observed to be folded in.Outside of the body, the occluder held the bulbous shape.There was no kink or angulation in the delivery system and no interaction with cardiac structures.There was no reported patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient was reported to be discharged.
Additional Manufacturer Narrative
An event of tip of the sheath was folded was reported.The delivery cable, hemostasis valve, stopcock, and extension tube were received for examination, and the blue tip of the sheath was observed to be folded in.The returned loader contained two small kinks.It was indicated that device was deployed and multiple attempts to recaptured during the procedure which may have contributed to the reported event of material invagination.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: 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: 17861325
• Report Number: 2135147-2023-04284
• Device Sequence Number: 17565896
• Product Code: DQY
• UDI-Device Identifier: 05415067030955
• UDI-Public: 05415067030955
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ATV12F45/80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO DELIVERY SYSTEM
• Patient Age: 43 YR
• Patient Sex: Female