MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE OTW NITINOL STENT; SELF EXPANDING STENTS (NIM)

Catalog Number P10040XC

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

Patient Problems Paresis (1998); Vascular System (Circulation), Impaired (2572)

Event Date 07/19/2014

Event Type  Injury  

Event Description

As noted in the publication by hayashi et al (2014), ¿pathophysiology of flow impairment during carotid artery stenting with an embolus protection filter,¿ it was noted that a patient having balloon angioplasty for symptomatic right internal carotid artery (ica) stenosis experienced flow arrest after having a 10x40mm precise stent placed in the common carotid artery (cca).Flow was restarted after filter retrieval.Postoperatively, the patient suffered from mild left hemiparesis and the mri diffusion-weighted image showed multiple high-intensity lesions in the right cerebral hemisphere.Filter observation showed 78.4 % of the area was occupied with debris and fibrin.The occupied area was 0.463 cm2 and the fibrin precipitation was 0.185 cm2.The cause of the flow impairment was filter obstruction.All procedures were performed via the femoral approach using an 8 fr guiding catheter.A 5 fr angioguard embolic protection filter was employed to prevent distal embolism during stenting.Following predilation a 10x40mm precise stent was deployed from the internal carotid artery (ica) to the common carotid artery (cca).After stent deployment post-dilation was performed with a balloon matched to the distal reference vessel diameter in order to achieve an optimal stenting result.Following stenting and postdilation the angiogram revealed flow arrest.Then the angioguard embolic protection filter was retrieved with a capture catheter.

Manufacturer Narrative

This article was found during a recent clinical evaluation review/literature search of this device.The catalog number of the device was estimated based on the information in the article.The citation is as follows: hayashi et al¿pathophysiology of flow impairment during carotid artery stenting with an embolus protection filter; (2014).Concomitant medical products: heparin was given during the procedure.Pre-procedure medications included aspirin and clopidogrel; 5 fr angioguard.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00543 and 1016427-2014-00100.

Manufacturer Narrative

As noted in the publication by hayashi et al (2014), ¿pathophysiology of flow impairment during carotid artery stenting with an embolus protection filter,¿ it was noted that a patient having balloon angioplasty for symptomatic right internal carotid artery (ica) stenosis experienced flow arrest after having a 10x40mm precise stent placed in the common carotid artery (cca).Flow was restarted after filter retrieval.Postoperatively, the patient suffered from mild left hemiparesis and the mri diffusion-weighted image showed multiple high-intensity lesions in the right cerebral hemisphere.Filter observation showed 78.4 % of the area was occupied with debris and fibrin.The occupied area was 0.463 cm2 and the fibrin precipitation was 0.185 cm2.The cause of the flow impairment was filter obstruction.All procedures were performed via the femoral approach using an 8 fr guiding catheter.A 5 fr angioguard embolic protection filter was employed to prevent distal embolism during stenting.Following predilation a 10x40mm precise stent was deployed from the internal carotid artery (ica) to the common carotid artery (cca).After stent deployment post-dilation was performed with a balloon matched to the distal reference vessel diameter in order to achieve an optimal stenting result.Following stenting and postdilation the angiogram revealed flow arrest.Then the angioguard embolic protection filter was retrieved with a capture catheter.The sterile lot numbers of each device are unknown therefore a device history report review could not be conducted.Hemiparesis and hypoperfusion are well-known potential adverse events associated with the carotid stent implantation procedure.Hemiparesis symptoms are similar to those of stroke but do not last as long.Typically symptoms of hemiparesis often last only a few minutes, most symptoms resolve within an hour but they may last up to 24 hours.Hemiparesis occurs when the blood supply to part of the brain is briefly interrupted.The hemodynamic instability that occurs both during and after carotid stent implantation is influenced by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds (stent delivery system) and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This results in a fall in blood pressure and bradycardia.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events associated with the compression of the baro-receptors during balloon inflation, stent implantation and filter device manipulation.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.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.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00543 and 1016427-2014-00100.

• Brand Name: PRECISE OTW NITINOL STENT
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): 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: 4036689
• MDR Text Key: 21728699
• Report Number: 9616099-2014-00543
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: P10040XC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 8 FR GUIDING CATHETER
• Patient Outcome(s): Disability
• Patient Age: 74 YR