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

Catalog Number PC0530RXC

Device Problem Occlusion Within Device (1423)

Patient Problem Infarction, Cerebral (1771)

Event Date 07/25/2013

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: (b)(6) female patient with a history of congestive heart failure, coronary artery disease with past coronary bypass surgery and stenting, poorly controlled diabetes mellitus and hypertension, morbid obesity, and stage 4 renal disease on dialysis experienced an acute left hemisphere, watershed ischemic stroke approximately nine months after precise stent placement and experienced a myocardial infarction (mi), cardiac arrest, left internal carotid artery (ica) instent occlusion/restenosis, and irreversible anoxic bilateral brain injury approximately five days after three enterprise and one precise pro stents were implanted in the left ica.Prior to the stenting procedures, the patient presented with 90% stenosis of the left intracranial, distal cervical and cervical internal carotid artery with symptoms of slurred speech and word finding difficulty.She was treated with angioplasty and placement of a 5.0 x 20mm precise pro stent in the distal internal carotid artery that was post-dilated with a 3.0 x 30mm balloon.A 3.0 x 21mm wallstent was then deployed from the left internal to the left common carotid artery.There was 20% residual stenosis and persistent intracranial left internal carotid artery stenosis.Approximately nine months later, she presented with an acute left hemisphere watershed ischemic stroke and stent restenosis.She had stopped taking her aspirin and plavix approximately two months previous to the event.After angioplasty, three enterprise stents (4.5 x 37mm x 1 and 4.5 x 28mm x2) were advanced into the distal ica through a prowler plus microcatheter.Stents were deployed starting from the cavernous ica proximally to the petrous internal carotid artery and connecting with her previous stent in the area.Following this, a 5.0 x 30mm precise pro stent was deployed between 2 cervical internal carotid stents.Post stenting runs showed good stent placement and no evidence of an embolic event.The patient did well and was discharged to another facility the following day for treatment of multiple ongoing cardiovascular and medical problems that included coronary artery disease and stage 4 renal disease.Approximately 5 days after the stenting procedure, she suffered an mi with cardiac arrest and was resuscitated and treated with hypothermia.She was then transferred back to the other facility and underwent stenting of the mid and distal circumflex arteries.The patient was minimally responsive with extensor posturing to deep pain, and was on a ventilator.Ultrasound and ct suggested bilateral infarcts in the ¿watershed¿ distribution, and occlusion of the left ica at the skull base with no flow seen in the distal portion of the left ica stent, consistent with complete restenosis.The physician reported that it was difficult to know when the carotid occlusion occurred, and it is likely that occlusion was related to the interruption of flow associated with the cardiac arrest.No additional information regarding the patient¿s current condition could be obtained.The devices were implanted and not available for analysis.A review of the manufacturing documentation associated with the lot numbers provided presented no issues during the manufacturing process that can be related to the reported complaint.Thrombosis, cerebrovascular accident and restenosis are known potential adverse events associated with stent implantation procedures, and are listed in the ifu as such.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the stent around the damaged areas.Occlusion/thrombosis/restenosis of the stent can results in decreased blood flow and distal embolization that can result in cerebral ischemia.However, this patient experienced an mi and cardiac arrest related to her pre-existing coronary artery disease, and the interruption of blood flow associated with the cardiac arrest may have contributed to the carotid occlusion and brain ischemia.The enterprise stent in intended for use with embolic coils and is not indicated for treatment of vascular occlusions, therefore, safety data for off-label use is not available.There is no evidence that the complaint was related to a design or manufacturing issue, therefore, no corrective actions will be taken at this time.This is one of five mdr reports that are being submitted for this complaint (sr# (b)(4)).(b)(6).

Event Description

A patient experienced an acute left hemisphere, watershed ischemic stroke approximately nine months after precise stent placement and experienced a myocardial infarction (mi), cardiac arrest, left internal carotid artery (ica) instent occlusion/restenosis, and irreversible anoxic bilateral brain injury approximately five days after three enterprise and one precise pro stent was implanted in the left ica.Prior to the stenting procedures, the patient presented with 90% stenosis of the left intracranial, distal cervical and cervical internal carotid artery with symptoms of slurred speech and word finding difficulty.She was treated with angioplasty and placement of a 5 x 20mm precise pro stent in the distal internal carotid artery that was post-dilated with a 3 x 30mm balloon.A 3.X 21mm wallstent was then deployed from the left internal to the left common carotid artery.There was 20% residual stenosis as well as persistent intracranial left internal carotid artery stenosis.Approximately nine months later, she presented with an acute left hemisphere watershed ischemic stroke and stent restenosis.She stopped taking aspirin and plavix 2 months previously.After angioplasty, three enterprise stents (one 4.5 x 37mm and two 4.5 x 28mm) were advanced into the distal ica through a prowler plus microcatheter.Stents were deployed starting from the cavernous ica proximally to the petrous internal carotid artery and connecting with her previous stent in the area.Following this, a 5.0 x 30mm precise pro stent was deployed between 2 cervical internal carotid stents.Post stenting runs showed good stent placement and no evidence of embolic event.The patient did well and was discharged to another facility the following day for treatment of multiple ongoing cardiovascular and medical problems that included coronary artery disease and stage 4 renal disease.

Manufacturer Narrative

While at the other facility, approximately 5 days after the stenting procedure, she suffered an mi with cardiac arrest.Following resuscitation and treatment with hypothermia, she was transferred back to the initial hospital.She underwent stenting of the mid and distal circumflex arteries.The patient was minimally responsive with extensor posturing to deep pain, and was on a ventilator.Ultrasound and ct suggested bilateral infarcts in the ¿watershed¿ distribution, and occlusion of the left ica at the skull base with no flow seen in the distal portion of the left ica stent, consistent with complete restenosis.The physician reported that it was difficult to know when the carotid occluded, and it is likely that occlusion was related to the interruption of flow associated with the cardiac arrest.No additional information regarding the patient¿s current condition could be obtained.Concomitant medications included: soma 350mg, aspirin 325mg daily atorvastatin 20mg daily, coreg 25mg twice daily, plavix 75mg daily lasix 20mg daily, novalog insulin 25 units with each meal, levemir insulin 24 units at bedtime, omeprazole 20mg daily, xanax 2mg 3 times daily, and metoclopramide 10mg with meals.Additional information will be submitted within 30 days of receipt.This is one of five mdr reports that are being submitted for this complaint (sr# (b)(4)).The involved pi numbers are 1-jz14o0, 1-jyp5ue, 1-jxmxs7, 1-jwrol5, and 1-jwrohs.Yp5ue, 1-jxmxs7, 1-jwrol5, 1-jwrohs.

• 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 (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3557999
• MDR Text Key: 11536634
• Report Number: 9616099-2014-00017
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: PC0530RXC
• Device Lot Number: 15754717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR