MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 6.0X40 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Stroke/CVA (1770); Vasoconstriction (2126)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During post-dilatation of an 8mm x 4mm precise stent with a 5mm x 4cm aviator plus balloon catheter, the physician was unable to successfully withdraw the balloon catheter.The removal caused movement of the angioguard embolic protection device in place, resulting in severe spasm of the left internal carotid artery.It also resulted in transient thrombotic occlusion of the internal carotid artery and the patient suffered a stroke.There was also difficulty closing and removing the angioguard device which was removed partially collapsed.The thrombus was aspirated.The patient suffered a stroke complaining of right arm and leg weakness, expressive dysphasia and confusion.An urgent ct scan was performed and this did not reveal any acute stroke or haemorrhage.The patient was treated conservatively by the radiology nursing staff and made a significant recovery in the radar analysis and development unit (radu).The patient was converted from aspirin to clopidogrel.The patients arm and leg weakness resolved, he was less confused but still had some residual expressive dysphasia.A left carotid stenting procedure was being performed.Under ultrasound guidance a left common femoral artery puncture was performed and a short 6 inserted.The patient was 5000 units of heparin intravenously.Selective catheterization was performed to the left common carotid artery using a 5 french catheter.Angiography demonstrated a high-grade focal stenosis at the origin of the internal carotid artery.A long 6 french sheath was inserted into the common carotid artery.The stenosis was crossed intraluminal using a 5 mm angioguard.The stenosis was predilated uneventfully using a 3 mm x 4 cm balloon.An 8 mm x 4 cm cordis precise stent was deployed uneventfully.The stent was post-dilated uneventfully using a 5 mm x 4 cm balloon.There was still a residual stenosis and therefore further balloon dilatation was attempted using a 6 mm x 4 cm balloon.There was marked resistance to during the distal portion balloon catheter over the guide wire.Numerous maneuvers were attempted to remove the balloon catheter is all unsuccessful.Considerable force was required, and this resulted in movement of the angioguard filter protection device.The force needed to remove balloon which resulted in movement of the angioguard filter protection device which resulted in severe spasm in the left internal carotid artery.Eventually the balloon was removed.Attempts were made to remove and close the filter protection device.This was also problematic due to the presence of a large amount of fresh thrombus in the distal filter.This was eventually removed partially collapsed.The sheath was withdrawn from the carotid artery and a large amount of thrombus aspirated.Eventually the left carotid artery cleared.There was no obvious result filling defect and the intracranial circulation appeared preserved.An angioseal was deployed to the groin to achieve hemostasis.The aviator will be returned for analysis.
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This is one of three devices associated with the reported event but the related numbers will be provided in the related reports.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was returned and section d9 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During post-dilatation of an 8mm x 4mm precise stent with a 5mm x 4cm aviator plus balloon catheter, the physician was unable to successfully withdraw the balloon catheter.The removal caused movement of the angioguard embolic protection device in place, resulting in severe spasm of the left internal carotid artery.It also resulted in transient thrombotic occlusion of the internal carotid artery and the patient suffered a stroke.There was also difficulty closing and removing the angioguard device which was removed partially collapsed.The thrombus was aspirated.The patient suffered a stroke complaining of right arm and leg weakness, expressive dysphasia and confusion.An urgent ct scan was performed, and this did not reveal any acute stroke or hemorrhage.The patient was treated conservatively by the radiology nursing staff and made a significant recovery in the radar analysis and development unit (radu).The patient was converted from aspirin to clopidogrel.The patients arm and leg weakness resolved, he was less confused but still had some residual expressive dysphasia.A left carotid stenting procedure was being performed.Under ultrasound guidance a left common femoral artery puncture was performed and a short 6 inserted.The patient was 5000 units of heparin intravenously.Selective catheterization was performed to the left common carotid artery using a 5 french catheter.Angiography demonstrated a high-grade focal stenosis at the origin of the internal carotid artery.A long 6 french sheath was inserted into the common carotid artery.The stenosis was crossed intraluminal using a 5 mm angioguard.The stenosis was predilated uneventfully using a 3 mm x 4 cm balloon.An 8 mm x 4 cm cordis precise stent was deployed uneventfully.The stent was post-dilated uneventfully using a 5 mm x 4 cm balloon.There was still a residual stenosis and therefore further balloon dilatation was attempted using a 6 mm x 4 cm balloon.There was marked resistance to during the distal portion balloon catheter over the guide wire.Numerous maneuvers were attempted to remove the balloon catheter is all unsuccessful.Considerable force was required, and this resulted in movement of the angioguard filter protection device.The force needed to remove balloon which resulted in movement of the angioguard filter protection device which resulted in severe spasm in the left internal carotid artery.Eventually the balloon was removed.Attempts were made to remove and close the filter protection device.This was also problematic due to the presence of a large amount of fresh thrombus in the distal filter.This was eventually removed partially collapsed.The sheath was withdrawn from the carotid artery and a large amount of thrombus aspirated.Eventually the left carotid artery cleared.There was no obvious result filling defect and the intracranial circulation appeared preserved.An angioseal was deployed to the groin to achieve hemostasis.The aviator will be returned for analysis.The device was returned for analysis.One non-sterile aviator plus.014 6.0x40 142cm was received coiled inside a plastic bag.Also, an angioguard embolic protection device was received along the unit and not inserted into the unit.The angioguard device evaluation will be documented under (b)(4) complaint.Per visual analysis, the balloon looks like it has been previously inflated.No other anomalies were observed on the unit.Per functional analysis, the catheter was successfully flushed.Neither obstruction nor resistance was observed during the flushing procedure.The returned angioguard device couldn¿t be passed through the aviator unit since the angioguard device was already deployed.However, a 0.014¿ cordis guidewire lab sample was passed successfully through the guidewire lumen from the hub port to the distal tip and from the distal tip to the hub port, and neither resistance nor obstruction was observed during the insertion/withdrawal test.A product history record (phr) review of lot 82201996 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - withdrawal difficulty - snagged/ caught on stent¿ was not confirmed since the event reported cannot be properly evaluated due to the nature of the complaint.However, the guidewire was passed successfully through the unit and neither resistance nor obstruction was observed during the insertion/withdrawal test.The reported arterial spasm and stroke were not confirmed since the event reported cannot be properly evaluated due to the nature of the complaint.Procedural and/or handling factors might have contributed to the reported condition of the unit since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.With the limited amount of information available regarding lesion characteristics and without the return of all the devices for analysis it is difficult to draw a clinical conclusion between the devices and the events reported.Risks associated with angioplasty procedures include arterial spasm and stroke.In this case (arterial spasm and stroke was specifically reported).These are well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal plaque rupture during interventional procedures.Review of the available information suggests that these lesion characteristics and possibly procedural factors may have contributed to the withdrawal difficulty.During the investigation conducted, it was reported that ¿numerous maneuvers were attempted to remove the balloon catheter is all unsuccessful.Considerable force was required, and this resulted in movement of the angioguard filter protection device.The force needed to remove balloon which resulted in movement of the angioguard filter protection device which resulted in severe spasm in the left internal carotid artery.Eventually the balloon was removed.¿ therefore, it can be concluded that the operator¿s interaction with the balloon catheter (considerable force required) caused movement of the angioguard, resulting in an arterial spasm which resulted in the patient experiencing stroke like symptoms.The operator¿s direct interaction with the devices caused the reported events.A calcified/resistant lesion can cause damage to the balloon and result in vessel damage during angioplasty.According to the instructions for use ¿prior to use, the device should be examined to verify functionality and integrity and ensure that its size is suitable for the specific procedure.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in-vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure-monitoring device is recommended to prevent over-pressurization.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.Potential complications, which may lead to additional intervention, include, but are not limited to: embolism, hemorrhage, stroke, thrombosis, transient ischemic attack, vascular complications (e.G.Intimal tear, dissection, pseudoaneurysm, perforation, rupture, spasm, occlusion).¿ furthermore, it was reported that ¿attempts were made to remove and close the filter protection device.This was also problematic due to the presence of a large amount of fresh thrombus in the distal filter.This was eventually removed partially collapsed.¿ however, in the instructions for use (ifu) it clearly states the following ¿how to detect if the angioguard rx emboli capture guidewire is full 1.Once the angioguard rx emboli capture guidewire is deployed in the vessel, it may capture emboli during the entire time of the interventional procedure.Therefore, it is recommended to check the status of the angioguard rx emboli capture guidewire at regular intervals during the intervention.2.Using fluoroscopy, perform a distal dye injection through the guiding catheter or interventional sheath introducer and observe the flow of dye distal to the filter basket or distal marker on the guidewire.3.If the distal perfusion of dye is significantly reduced or no dye is perfusing past the filter basket or guidewire distal marker band, the angioguard rx emboli capture guidewire may have reached its capacity to contain emboli.If there is a severe reduction in distal dye perfusion, it is recommended to exchange the angioguard rx emboli capture guidewire for a new one.¿ to exchange an angioguard rx emboli capture guidewire system that has captured its capacity of emboli the operator must follow the instructions for use in its entirety.If the operator would have followed the instructions for use properly, the operator would have read that ¿note: the emboli that have been captured may not allow the angiogard rx emboli capture guidewire to reach its initial low profile.¿ in conclusion, no procedural films nor images were provided for the reported adverse events of arterial spasm and stroke.Neither the phr, the analysis for the returned devices nor the information available suggests a design or manufacturing related cause for the reported events.Therefore, no corrective or preventive action will be taken at this time.This is one of three devices associated with the reported event.The two related report numbers are 9616099-2021-05044 and 1016427-2021-05377.

• Brand Name: AVIATOR PLUS .014 6.0X40 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12778478
• Report Number: 9616099-2021-05043
• Device Sequence Number: 3708083
• Product Code: LIT
• UDI-Device Identifier: 20705032005927
• UDI-Public: (01)20705032005927(17)230831(10)82201996
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071189
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2022

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 4246040W
• Device Lot Number: 82201996
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 01/13/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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: PRECISE AND ANGIOGUARD
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male