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

Model Number	9-ATV07F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2021, a 6mm amplatzer duct occluder and a 6/4mm amplatzer duct occluder ii were implanted.Post-implant, vascular hematoma and active bleeding from the left femoral puncture site was observed and manual compression was applied.Of note, an episode of hypotension was observed and related to the bleeding.The patient was transfused 1 unit of packed red blood cells.No patient consequences were reported.On (b)(6) 2021, additional information received reported that the 7f amplatzer trevisio delivery system (batch/lot: 7507123) was used in the left access site.An additional 6mm amplatzer duct occluder (batch/lot: 6987723) was attempted to be implanted, however the occluder embolized to the pulmonary artery and was retrieved via snare.In addition, the 5mm amplatzer duct occluder (batch/lot: 7456394) was mis-sized.Clinical study patient id: (b)(6).
Additional Manufacturer Narrative
An event of "vascular hematoma and active bleeding from the left femoral puncture site" was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident 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 north; plymouth MN 55442
• MDR Report Key: 11806312
• Report Number: 2135147-2021-00181
• Device Sequence Number: 19716548
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 04/30/2023
• Device Model Number: 9-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 7507123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 62