MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X60ML; STENT, ILIAC

Catalog Number	C06060ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing documentation associated with this lot 15642766 presented no issues during the manufacturing process that can be related to the reported complaint.This device remains implanted, therefore is not available for return.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported by the (b)(6) study, a smart 120 150, superficial femoral artery (sfa) - 6 x 150 mm stent and a smart control, iliac 6 x 60 ml stent were implanted in the target lesion without any issue.Approximately 4 years, 2 months post index procedure, the patient developed asymptomatic stent thrombosis.Abi and dus confirmed the occlusion.The thrombosis was inside and the edge of the stent(s).Rutherford exam was not done, and no treatment was applied.The patient was a (b)(6) female.The target lesion was the middle portion of the left superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was mildly calcified.The rate of stenosis was unknown.
Additional Manufacturer Narrative
The sections have been updated accordingly: as reported by the japan smart pms study, a smart 120 150, superficial femoral artery (sfa) - 6 x 150 mm stent and a smart control, iliac 6 x 60 ml stent were implanted in the target lesion without any issue.Approximately 4 years, 2 months post index procedure, the patient developed asymptomatic stent thrombosis.Abi and dus confirmed the occlusion.The thrombosis was inside the edge of the stent(s).Rutherford exam was not done, and no treatment was applied.The patient was a (b)(6) female.The target lesion was the middle portion of the left superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was mildly calcified.The rate of stenosis was unknown.Medications patient was currently taking at home was aspirin and clopidogrel.The procedure in which the smart was implanted was an emergent procedure performed as a bailout for poba (3mm×100mm).This was a de novo lesion.The stent to vessel sizing was 5.0mm.Post-procedure regime of antiplatelet therapy was aspirin and clopidogrel.The patient was compliant with the antiplatelet therapy.The patient is currently doing fine.Additional procedural details were requested but are unknown.Neither of the two products were returned for analysis.A device history record (dhr) review of lot 15845969 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.A device history record (dhr) review of lot 15642766 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without procedural films available for review, the reported stent thrombosis could not be confirmed.A thrombosis is the formation of a clot within a vessel, or in this case, a stent.Thrombosis and treatment for thrombosis does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
Event or Problem Description
As reported by the (b)(4) smart pms study, a smart 120 150, superficial femoral artery (sfa) - 6 x 150 mm stent and a smart control, iliac 6 x 60 ml stent were implanted in the target lesion without any issue.Approximately 4 years, 2 months post index procedure, the patient developed asymptomatic stent thrombosis.Abi and dus confirmed the occlusion.The thrombosis was inside and the edge of the stent(s).Rutherford exam was not done, and no treatment was applied.The patient was a (b)(6) female.The target lesion was the middle portion of the left superficial femoral artery.The patient¿s vessel level of tortuousness was unknown.The lesion was mildly calcified.The rate of stenosis was unknown.Medications patient was currently taking at home was aspirin and clopidogrel.The procedure in which the smart was implanted was an emergent procedure on (b)(6) 2013 bailout for poba (3mm×100mm).This was a de novo lesion.The stent to vessel sizing was 5.0mm.Post-procedure regime of anti platelet therapy was aspirin and clopidogrel.The patient was compliant with the anti platelet therapy.The patient is currently doing fine.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 6X60ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7084093
• Report Number: 9616099-2017-01653
• Device Sequence Number: 16426659
• Product Code: NIO
• UDI-Device Identifier: 20705032023532
• UDI-Public: 20705032023532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 05/31/2014
• Device Catalogue Number: C06060ML
• Device Lot Number: 15642766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDING SHEATH: 6FRGUIDEWIRE: 18INCH
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Weight: 36