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

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.

• 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 Key: 9868382
• MDR Text Key: 190013523
• Report Number: 9616099-2020-03589
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• 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 Date: 10/31/2021
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17910556
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 98