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U.S. Department of Health and Human Services

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

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CORDIS DE MEXICO PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM) Back to Search Results
Catalog Number PC0830RXC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 01/03/2014
Event Type  Injury  
Event Description
As reported via the (b)(6) registry, a patient experienced a grade c dissection after pre-dilation during a carotid index procedure.Also, reported, patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Pre-procedure nih stroke scale was 2, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 95% stenosis to the left proximal internal carotid artery.The lesion was described as concentric.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.It was noted that the angioguard did not malfunction but it was not removed because the patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Concomitant medications included clopidogrel and aspirin at pre-procedure.Per the investigator, the event was not related to the cordis products but related to the index procedure.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15916584 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Concomitant medications included clopidogrel and aspirin at pre-procedure.Additional information will be submitted within 30 days of receipt.This is one of two products involved with this adverse event in which associated manufacturer report numbers are 9616099-2014-00116 and 1016427-2014-00022.
 
Manufacturer Narrative
Complaint conclusion: this (b)(6) female enrolled in the sapphire registry study reported via the sapphire registry, a patient experienced a grade c dissection after pre-dilation during a carotid index procedure.Also, reported, patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Pre-procedure nih stroke scale was 2, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 95% stenosis to the left proximal internal carotid artery.The lesion was described as concentric.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.It was noted that the angioguard did not malfunction but it was not removed because the patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Concomitant medications included clopidogrel and aspirin at pre-procedure.Per the investigator, the event was not related to the cordis products but related to the index procedure.The patient¿s medical history includes hyperlipidemia,cabg and coronary artery disease.No other information is available.(b)(4).The product remains implanted in the patient and thus not available for evaluation.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Dissection is a 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 dissection during interventional procedures.The physical manipulation inherent in the stent implantation procedure intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.Based on the information received, the event was related to the procedure.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.Therefore no corrective and preventive actions will be taken at this time.Carotid artery angioplasty has emerged as a potential therapeutic alternative for atherosclerotic disease.There are several possible complications resulting from the procedure, but carotid artery rupture is very rare, and the management ranges from conservative to open surgery.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.Therefore no corrective and preventive actions will be taken at this time.Without the return of the device for analysis, the reported events could not be confirmed.
 
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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
aaron goodstein
miami lakes, FL 33014
63136118
MDR Report Key3636986
MDR Text Key18856167
Report Number9616099-2014-00116
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030047
Number of Events Reported1
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 01/26/2014
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 Date05/31/2015
Device Catalogue NumberPC0830RXC
Device Lot Number15916584
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/17/2014
Initial Date FDA Received02/20/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age84 YR
Patient Weight50
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