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

Model Number	9-ITV10F45/80
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); Seizures (2063); Decreased Respiratory Rate (2485)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of air embolism was reported.A more comprehensive assessment could not be performed since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020, an amplatzer pfo occluder was selected for implant in a (b)(6) male with a comorbidity of cerebral infarction.During the implant procedure the patient was under local anesthesia and sedative, but hypopnea and a decrease in blood pressure were observed.During the procedure the physician used an amplatzer torqvue delivery system (lot#6960433) and upon withdrawal of the dilator from the delivery sheath, the patient snored loudly and inferior lead, st elevation, and additional blood pressure decrease were confirmed on the ecg monitor.An air bubble entered upon withdrawal of the sheath causing an air embolus in the coronary artery.The physician suspects that air came into the sheath when connecting the loading assembly to the sheath and the lack of a hemostasis valve being on the sheath can allow for air to enter.The patient was immediately put under general anesthesia for stabilizing their blood pressure.There was no neural problem and the patient¿s blood pressure and breathing stabilized, therefore the pfo was successfully deployed in the patient¿s defect.Due to the following events, there was a 30 minute delay in the procedure.During extubation the patient experienced a seizure thought to be due to the hypotension and low cerebral blood flow.Ct and mri were used to confirm that there was no new cerebral infarction or vascular occlusion in the patient.The patient was administered anticoagulant and anticonvulsant.The seizure was eliminated, but the patient became paralyzed on the left side of the body.Over the next few days the patient gradually improved with the medication given and rehabilitation.On (b)(6) 2020 the patient was transferred to another hospital specializing in rehabilitation and on (b)(6) 2020 the patient recovered and was discharged.
Additional Manufacturer Narrative
An event of air embolism was reported.A more comprehensive assessment could not be performed since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.While air embolism is a known potential adverse event per the instructions for use (ifu) artmt100092315 rev.B, the warnings section states "remove the dilator and sheath from the patient slowly to prevent an ingress of air." the following ifu steps are intended to mitigate risk of potential ingress of air: 9.Allow blood backflow to purge any air from the sheath.10.Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline.12.Attach the distal end of the loader to the proximal end of the sheath.Turn the rotating luer on the loader clockwise to lock the components together.Remember to close the stopcock on the hemostasis valve.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10121121
• Report Number: 2135147-2020-00252
• Device Sequence Number: 2143024
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: 00811806010878
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072313
• 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): 07/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 6960433
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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: 63 YR
• Patient Weight: 65