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 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.

• 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 Key: 3636986
• MDR Text Key: 18856167
• Report Number: 9616099-2014-00116
• 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: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 15916584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 50