MAUDE Adverse Event Report: CORDIS CASHEL SMART 120 150, SFA - 7X120MM; STENT, ILIAC

Catalog Number	C07120ML
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was enrolled in a clinical study and had a 120/150 smart sfa 7 x 120 stent successfully implanted in the mid left femoral artery target lesion without any issue during the study index procedure.No target lesion characteristic information was available.Three (3) years seven (7) months and three (3) days after the index procedure, the patient experienced in-stent-restenosis (isr) of the previously implanted smart study stent and target lesion revascularization (tlr) was performed.The patient was reported to have recovered.The event was reported to be unrelated to the study device/procedure.Additional information received indicated that the percent of in stent restenosis reported was not known.No additional target lesion characteristic information was available.There was no specific information available as to the intervention performed to treat the isr.It was unknown what the patient¿s medical regimen post-procedure was or if the patient was compliant with the medical regimen.No additional information is available.The product was not returned for analysis.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Based on the information provided and the inability to assign or determine a root cause, no corrective actions will be taken at this time.Without procedural films for review, the event reported by the customer cannot be confirmed.Restenosis is a known potential adverse event associated with implanting peripheral artery stents and is often associated with the progression of peripheral vascular/artery disease.Based on the available information there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.Please note that this is the initial/final report for this product.
Event or Problem Description
As reported, the patient was enrolled in a clinical study (b)(6) for sfa and the case number is (b)(6).The patient had a 120/150 smart sfa 7 x 120 stent successfully implanted in the mid left femoral artery target lesion without any issue during the study index procedure.No target lesion characteristic information was available.Three (3) years seven (7) months and three (3) days after the index procedure, the patient experienced in-stent-restenosis (isr) of the previously implanted smart study stent and target lesion revascularization (tlr) was performed.The patient was reported to have recovered.The event was reported to be unrelated to the study device/procedure.Additional information received indicated that the percent of in stent restenosis reported was not known.No additional target lesion characteristic information was available.There was no specific information available as to the intervention performed to treat the isr.It was unknown what the patient¿s medical regimen post-procedure was or if the patient was compliant with the medical regimen.No additional information is available.

• Brand Name: SMART 120 150, SFA - 7X120MM
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 6808267
• Report Number: 9616099-2017-01342
• Device Sequence Number: 992757
• Product Code: NIO
• UDI-Device Identifier: 20705032063422
• UDI-Public: 20705032063422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: C07120ML
• Device Lot Number: 15849815
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 61