MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM)

Catalog Number PC0830RXC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 05/02/2014

Event Type  Injury  

Event Description

As reported via the sapphire registry, a patient experienced an ischemic stroke twenty-five days post procedure.The event resolved fully.Pre-procedure nih stroke scale score was 0, stroke scale score was 0 and the patient was symptomatic.At the time of the index procedure, angiography revealed 90% stenosis to the right proximal internal carotid artery.The lesion was described as 22.8mm in length and arch type i.The reference vessel was 4.6 in diameter.A 6mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 8.0 x 30mm precise pro rx was implanted at the target lesion.The angioguard was retrieved successfully.Debris was not noted in the filter basket.No air bubbles were present.There was 0% residual stenosis.The patient left the angiography suite with no neurological deficits.The post-procedure nih stroke scale score was 0 and the stroke scale score was 0.The patient was discharged on the next day.Concomitant medications included clopidogrel and asprin at pre/post procedure and at discharge.Twenty-five days post procedure, the patient was hospitalized due to sudden left visual field loss, left hemiparesis, dysarthia and amaurosis fugax.He had difficulty with his swallowing.The duration of the symptoms was more than 24 hours and was noted as fully resolved.The event was diagnosed as an ischemic stroke.The post nih stroke scale score on the onset of the event was 0 and the stroke scale score was 1.Per the investigator, the event was not related to the index procedure or the cordis devices.Additional information indicated that a ct angiography demonstrated patency of the stent.Mri of the brain ((b)(6) 2014) confirmed the presence of periventricular stroke.No evidence of acute hemorrhage and no midline shift or edema.The patient was discharged on (b)(6) 2014.

Manufacturer Narrative

Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: as reported via the sapphire registry, a patient experienced an ischemic stroke twenty-five days post procedure.The event resolved fully.Pre-procedure nih stroke scale score was 0, stroke scale score was 0 and the patient was symptomatic.At the time of the index procedure, angiography revealed 90% stenosis to the right proximal internal carotid artery.The lesion was described as 22.8mm in length and arch type i.The reference vessel was 4.6 in diameter.A 6mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 8.0 x 30mm precise pro rx was implanted at the target lesion.The angioguard was retrieved successfully.Debris was not noted in the filter basket.No air bubbles were present.There was 0% residual stenosis.The patient left the angiography suite with no neurological deficits.The post-procedure nih stroke scale score was 0 and the stroke scale score was 0.The patient was discharged on the next day.Concomitant medications included clopidogrel and aspirin at pre/post procedure and at discharge.Twenty-five days post procedure, the patient was hospitalized due to sudden left visual field loss, left hemiparesis, dysarthria and amaurosis fugax.He had difficulty with his swallowing.The duration of the symptoms were more than 24 hours and was noted as fully resolved.The event was diagnosed as an ischemic stroke.The post nih stroke scale score on the onset of the event was 0 and the stroke scale score was 1.Per the investigator, the event was not related to the index procedure or the cordis devices.Additional information indicated that a ct angiography demonstrated patency of the stent.Mri of the brain ((b)(6) 2014) confirmed the presence of periventricular stroke.No evidence of acute hemorrhage and no midline shift or edema.The patient was discharged on (b)(6) 2014.The product remains implanted in the patient and thus is not available for evaluation.A device history record review was performed and showed that the lot of products met all requirements per the applicable manufacturing quality plan.Ischemic stroke 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.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 or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.80% 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.The product was not returned for analysis.No corrective or preventive action will be taken, given that; with the information provided the reported failure/event does not appear to be related to the manufacturing process.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3905172
• MDR Text Key: 17618786
• Report Number: 9616099-2014-00438
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 16032983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Weight: 125