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Model Number 9-ITV09F45/80
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Death (1802)
Event Date 03/20/2018
Event Type  Death  
Manufacturer Narrative
An event of an air embolism and patient death was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Event Description
On (b)(6) 2018, a complex atrial septal defect (asd) closure was attempted. Pre-procedural planning involved tee imaging showing two separate and distant asds, one multifenestrated (small and central) and the other a true secundum asd with a static measurement of roughly 10 mm. The procedure was initiated under general anesthesia and an 8f ice catheter was placed in the mid right atrium for echo guidance. Both asds were visualized and the multifenestrated asd was set to be closed first. The multifenestrated asd was crossed using a mp diagnostic catheter and a short 0. 035¿ guidewire. The distance between the two noted fenestrations was measured along with measurements from the defect to adjacent cardiac structures. An 18 mm amplatzer cribriform occluder (aco) was selected to close the multifenestrated defect. The aco was prepped and delivered in usual fashion over a 260 cm amplatz super stiff guidewire that was placed in the left upper pulmonary vein. The aco was deployed without incident and deemed successful as the multifenestration did not show residual shunting on ice. Focus was then turned to the asd and attempted crossing functioned as above. Initially, it was deemed that a diagnostic 0. 035¿ guidewire had passed through another fenestration lower than the previously closed multifenestrated asd. The decision was made to try to close this using another 18 mm aco but before that was attempted another access site was obtained via left femoral vein and the mp and 0. 035¿ j wire was advanced and crossed the true asd. The j wire was exchanged for the 260 cm amplatz super stiff which was placed in the left upper pulmonary vein. Next, the 18mm aco was prepped and delivered in normal fashion through the delivery system in the earlier documented additional fenestration. The left atrial disc was deployed and as it was being pulled back to the septum and visualized in another plane via ice, it was deemed the device was actually through the true asd. The device was recaptured and removed along with the delivery system in the right femoral vein without incident. Asd closure was set to be attempted via the left femoral access site with the wire still in place. A 24 mm amplatzer sizing balloon ii was advanced to straddle the asd and stop flow technique was utilized to measure the asd. Ice measurement matched closely with cine measurements obtained of the waist of the sizing balloon, 15mm and 15. 5mm. A 16 mm amplatzer septal occluder (aso) (lot: 6171926), was selected to close the asd but never introduced to the body. A 9f amplatzer torque 45 delivery system (lot unknown) was prepped for closure and advanced into the left atrium via the left femoral vein. The dilator was disconnected from the sheath in the mid right atrium and removed slowly, ensuring that the exposed end of the sheath was below heart level. As the dilator and wire was fully removed, the physician noted that there was no flow out of the exposed end of the sheath. A second later the physician noted that a large amount of air was introduced into the left atrium. Aspiration was attempted with no success. There was large st segment elevation noted and arterial access was obtained and selective angiography and flushing was performed. General anesthesia reversal was initiated. St segments returned to baseline. No neurological function was observed. Neurology was called and angiography of the head was performed, showing no large vessel occlusions. The patient started to show signs of neurological activity via hands moving and eyes opening. After the sheaths were removed, the patient was taken for ct with unknown results. Over the next two days there was no neurological improvement and the decision was made to remove care/support on (b)(6) 2018. The origin of the air embolism remains unknown. It is uncertain if the delivery system or a procedural complication led to this event.
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Manufacturer (Section D)
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
MDR Report Key7398446
MDR Text Key104402284
Report Number2135147-2018-00043
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2018 Patient Sequence Number: 1