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

Model Number	9-ATV07F45/80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6), 2020, during an asd procedure, the physician used a size 11 mm asd device, after balloon sizing measurement.As indicated, he used a 7f trevisio delivery system.After placement the device appeared on imaging to be misshaped, "concaved." at some point, he attempted to retrieve the asd device with the trevisio delivery system, and was unable to retrieve.The trevisio sheath lumen prolapsed outwards, making it impossible for the device to be retrieved back into sheath the physician made the decision to release the device and the device was determined to be fine and it remains in place.Related manufacturer reference number: 2135147-2020-00435.".
Additional Manufacturer Narrative
Additional information b5, d10, g4, g7, h2, h3, h6 ,h10.An event of failure retracting the device into the sheath was reported.The tip invagination was confirmed.Gross morphological examination revealed the sheath tip was inverted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The tip invagination is consistent with inability to retract the device into the sheath.Please note, per the instructions for use, artmt 100092311 revision b "caution: do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure( such as svc, pv, mv, cs, ao).".
Event or Problem Description
Related manufacturer reference number : 2135147-2020-00435.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10658241
• Report Number: 2135147-2020-00406
• Device Sequence Number: 3145874
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 9-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 7472683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: 9-ASD-011; 9-ASD-011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 80