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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

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CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID Back to Search Results
Model Number PC0840RXC
Device Problem Activation Failure (3270)
Patient Problems Stroke/CVA (1770); Seizures (2063)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, patient intended procedure was to stent the internal carotid artery.The patient presented initially with a 99% occlusion of the artery.The occlusion was passed with an 0.014 wire and no embolism protection device was used.A 4x20 pre dilatation balloon was inserted and inflated, after removal the 8mm x 40mm precise pro rx carotid stent was inserted and deployed.A 7x40 post dilation balloon was inserted and inflated.The balloon and wire were removed, and a final shot was taken with an open and patent vessel.However, during closing procedures was when the patient presented with stroke and seizure like symptoms, the patient at this time was intubated and physician sent the patient to computerized tomography (ct) for a stat ct angio.The ct read by a second physician showed indications of a closed or collapsed carotid artery.The patient was placed back onto the interventional radiology (ir) room table and intervention was restarted.A wire was re-passed across the lesion and stent.Multiple balloon attempts happened without success.The decision was made to place another 8mm x 30mm precise stent inside of the existing stent.After placement the vessel was again open.The patient was sent to intensive care unit (icu) still intubated.
 
Manufacturer Narrative
Complaint conclusion: the intended patient procedure was to stent the internal carotid artery.The patient presented initially with a(b)(4) occlusion of the artery.The occlusion was passed with an 0.014 wire and no embolism protection device was used.A pre dilatation balloon 4x20 was inserted and inflated.After removal, a precise pro 8mm x 40mm rx carotid stent was inserted and deployed.A post dilation balloon 7x40 was inserted and inflated.The balloon and wire were removed, and a final shot was taken with an open and patent vessel.However, during closing procedures was when the patient presented with stroke and seizure like symptoms.The patient at this time was intubated and the physician sent the patient to computerized tomography (ct) for a stat ct angiogram.The ct read by a second physician showed indications of a closed or collapsed carotid artery.The patient was placed back onto the interventional radiology (ir) room table and intervention was restarted.A wire was re-passed across the lesion and stent.Multiple balloon attempts happened without success.The decision was made to place another precise 8mm x 30mm stent inside of the existing stent.After placement, the vessel was again open.The patient was sent to intensive care unit (icu) still intubated.The device was not returned for analysis.A product history record (phr) review of lot 17910556 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent-ses- incomplete expansion¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as a vessel tortuosity (although unknown) and a carotid artery with 99% occlusion may had led to the incomplete expansion as well as the reported stroke and seizure.According to the instructions for use ¿potential adverse events that may be associated with stent placement include stroke and seizure¿.Ischemic stroke/cerebrovascular accident is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.Additionally, it was reported that ¿no embolism protection device was used¿.This act inherent to the procedure, may have contributed to the reported event.A blood vessel that is not blocked, but is extremely narrowed, can also cause an ischemic stroke.The blocked (such as the 99% occluded carotid artery as reported) or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.(b)(4) of all strokes are ischemic.During ischemic stroke, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells.Early medical intervention can halt this process and reduce the risk for irreversible complications.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.
 
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Brand Name
PRECISE PRO RX US CAROTID SYST
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
MDR Report Key9868382
MDR Text Key190013523
Report Number9616099-2020-03589
Device Sequence Number1
Product Code NIM
UDI-Device Identifier20705032036495
UDI-Public20705032036495
Combination Product (y/n)N
PMA/PMN Number
P030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/06/2020
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
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model NumberPC0840RXC
Device Catalogue NumberPC0840RXC
Device Lot Number17910556
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2020
Initial Date FDA Received03/23/2020
Supplement Dates Manufacturer Received04/01/2020
Supplement Dates FDA Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age65 YR
Patient Weight98
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