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

Catalog Number PC0830RXC

Device Problem Defective Component (2292)

Patient Problem Vasoconstriction (2126)

Event Date 03/25/2014

Event Type  Injury  

Manufacturer Narrative

As reported by the (b)(6) registry, during a carotid artery stenting (cas) procedure a carotid artery spasm was noted during deployment of a 9x40mm precise pro rx stent.It was also noted that the stent became compressed in the patient.A second precise pro rx was deployed overlapping the first stent.Cas was performed on a 90% occluded lesion in the ostium of the left internal carotid artery of 20mm in length in a 9.0mm vessel diameter with moderate vessel tortuosity.The lesion was eccentric and moderately calcified.A 6mm extra support embolic protection device was deployed past the lesion and a 9x40mm precise stent was deployed.The stent became compressed after a carotid artery spasm occurred as depicted by an angiogram showing a narrowing at the proximal end of the stent.A second precise pro rx was deployed overlapping the first stent with a residual diameter stenosis measured at 10%.The patient was neurologically intact upon leaving the angio suite.The patient was discharged on the following day with no reported patient injury.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.Vessel spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and is listed in the ifu (instructions for use) as such.Local vasospasm can be caused by the outward radial force and axial friction of the stent, or by the device manipulations inherent in any procedure causing endothelial irritation.A carotid vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow to the brain.This may lead to tia like symptoms such as muscular or neurological changes.Treatment of arterial spasms may include medications such as nitrates and calcium channel blockers.It was also noted that the stent became compressed after the carotid artery spasm occurred as depicted by an angiogram showing a narrowing at the proximal end of the stent.A second precise pro rx was deployed overlapping the first stent.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.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00271 and 1016427-2014-00047.

Event Description

As reported by the (b)(4) registry, during a carotid artery stenting procedure a carotid spasm was noted during deployment of a 9x40mm precise pro rx stent which also became compressed in the patient.A second precise pro rx was deployed overlapping the previous stent.Cas was performed on a 90% occluded lesion in the ostium of the left internal carotid artery of 20mm in length in a 9.0mm vessel diameter with moderate vessel tortuosity.The lesion was eccentric and moderately calcified.A 6mm extra support embolic protection device was past the lesion and a 9x40mm precise stent was deployed and became compressed after a carotid spasm (crinkling of the artery) because the angiogram showed narrowing at the proximal end of the stent.An 8x30mm precise pro rx stent was deployed proximal to the target lesion and overlapping the previous stent.The residual diameter stenosis measured 10%.There was no presence of air bubbles noted during the procedure.The patient was neurologically intact upon leaving the angio suite.The patient was discharged on the following day without any further events.

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.J wire, ima catheter, 5f sheath, 6f 90 cm sheath, 6mm angioguard, 8x30mm precise stent and mynx closure device.Concomitant medications: heparin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00271 and 1016427-2014-00047.

• 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: 3753255
• MDR Text Key: 11755884
• Report Number: 9616099-2014-00271
• 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: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 15936091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 63