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

Catalog Number PC0730XCE

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

Patient Problems Reocclusion (1985); Vascular System (Circulation), Impaired (2572)

Event Date 08/14/2013

Event Type  Injury  

Event Description

As reported in a publication, recurrent carotid in-stent restenosis treated with paclitaxel-eluting balloon: case report and review of literature.A (b)(6) man was admitted to our department for severe asymptomatic stenosis (>70%) of the left internal carotid artery (ica) and symptomatic occlusion of the right ica, diagnosed by triplex scan.He was an ex-smoker and had a past medical history of dyslipidemia, hypertension and radiation therapy for larynx carcinoma.He underwent left cas (precise stent 7×40-mm) with cerebral protection without complications and with good immediate results.He was kept as an outpatient, under statin and dual antiplatelet therapy.Approximately two years later, a routine ultrasound examination of the supra-aortic trunks had shown severe isr (>70%).The patient was treated with re-stenting (two precise stents of 8×30-mm + 7×30-mm), under filter protection, without residual stenosis and uneventful.Three years later, recurrent isr >70% (peak systolic velocity ¿ psv=453 cm/s) was detected at doppler ultrasound follow-up examination.It was decided to perform a deb angioplasty.The procedure was performed through right femoral approach, under local anesthesia.The left ica was engaged in a telescopic fashion with a triple coaxial system formed by a 6-f sheath and a preloaded 4-f diagnostic catheter over a 0.035-inch glidewire.An intravenous heparin bolus (100 u/kg) was given after sheath insertion.The 0.035-inch glidewire was exchanged for a 0.014-inch coronary wire and then the lesion was carefully crossed.Under distal embolic protection (emboshield abbott) the in-stent lesion was predilated using three peripheral artery balloons (armada abbott 3×40-mm + armada abbott 4×40-mm + viatrac abbott 5×20-mm).An over-the-wire paclitaxel-eluting balloon (in.Pact pacific 6×40-mm, medtronic invatec) was then used.The balloon was inflated at 8 atmospheres for one minute and was well tolerated.

Manufacturer Narrative

After the procedure, there was no residual stenosis and no angiographic evidence of flow-limiting dissection or distal embolization.The patient had an uneventful course and was discharged home by day two after dus that revealed complete hemodynamic resolution of the stenosis (psv=122 cm/s).Clinical and doppler ultrasound follow-up was performed at 1 and 6 months and shows no related complications and no signs of isr (psv=128 cm/s).Complaint conclusion: as reported in a publication, recurrent carotid in-stent restenosis treated with paclitaxel-eluting balloon: case report and review of literature.A (b)(6) man was admitted to our department for severe asymptomatic stenosis (>70%) of the left internal carotid artery (ica) and symptomatic occlusion of the right ica, diagnosed by triplex scan.He was an ex-smoker and had a past medical history of dyslipidemia, hypertension and radiation therapy for larynx carcinoma.He underwent left cas (precise stent 7×40-mm) with cerebral protection without complications and with good immediate results.He was kept as an outpatient, under statin and dual antiplatelet therapy.Approximately two years later, a routine ultrasound examination of the supra-aortic trunks had shown severe isr (>70%).The patient was treated with re-stenting (two precise stents of 8×30-mm + 7×30-mm), under filter protection, without residual stenosis and uneventful.Three years later, recurrent isr >70% (peak systolic velocity ¿ psv=453 cm/s) was detected at doppler ultrasound follow-up examination.It was decided to perform a deb angioplasty.The procedure was performed through right femoral approach, under local anesthesia.The left ica was engaged in a telescopic fashion with a triple coaxial system formed by a 6-f sheath and a preloaded 4-f diagnostic catheter over a 0.035-inch glidewire.An intravenous heparin bolus (100 u/kg) was given after sheath insertion.The 0.035-inch glidewire was exchanged for a 0.014-inch coronary wire and then the lesion was carefully crossed.Under distal embolic protection (emboshield abbott) the in-stent lesion was predilated using three peripheral artery balloons (armada abbott 3×40-mm + armada abbott 4×40-mm + viatrac abbott 5×20-mm).An over-the-wire paclitaxel-eluting balloon (in.Pact pacific 6×40-mm, medtronic invatec) was then used.The balloon was inflated at 8 atmospheres for one minute and was well tolerated.After the procedure, there was no residual stenosis and no angiographic evidence of flow-limiting dissection or distal embolization.The patient had an uneventful course and was discharged home by day two after dus that revealed complete hemodynamic resolution of the stenosis (psv=122 cm/s).Clinical and doppler ultrasound follow-up was performed at 1 and 6 months and shows no related complications and no signs of isr (psv=128 cm/s).The products remain implanted in the patient and are thus not available for evaluation.Additionally, as the sterile lot number was not available, device history record review could not be performed.In-stent restenosis (isr) is associated with the progression of atherosclerotic disease and is a known potential adverse event following stent implantation and does not represent a device failure.Intra-arterial stent placement is a treatment of the disease process, it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.Vessel occlusion, restenosis, intimal hyperplasia or recurrent strictures are well known documented potential complications of this type of procedure and are listed in the ifu as such.In the literature, in-stent stenosis rates range from 11% to 39% from 6 to 12 months after stent placement.Rates were higher in older patients with more severe atherosclerosis and depended on the type of stenosis treated.Isr is more prevalent in ostial stent placement procedures.Stenoses in stents are usually treated with intrastent pta or placement of a second stent.Factors that may have influenced this event include patient, procedural, pharmacological and lesion.The products were not returned for analysis.No corrective or preventive action will be taken, given that; with the information provided the reported failure/event does not appear to be related to the manufacturing process.The implant date was 2009.Please note that this medwatch report represents one of two products involved with this event which is associated with mfg.Report # 9616099-2014-00581 and 9616099-2014-00583.(b)(4).

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• 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: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4080430
• MDR Text Key: 4742176
• Report Number: 9616099-2014-00584
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PC0730XCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR