MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 6X150MM; SELF EXPANDABLE STENTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Reocclusion (1985); Thrombosis (2100)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and is thus not available for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.This is one of two devices associated with the reported event but the manufacturing report number is not available for the second product at this time.
Event or Problem Description
As reported by the (b)(4) study, approximately 5 years after two 6x150mm smart stents were implanted in the proximal to the distal portion of the left femoral artery, stent thrombosis was confirmed.The level of abi was 0.34 on the left and pulse of the left popliteal artery was weak.Slight claudication was confirmed as well.Therefore, it was diagnosed as in stent restenosis on the left superficial femoral artery.There was no treatment provided.On the same day, the patient recovered.The event was considered serious, not related to the study devices and the reason of its relevancy judgment was the primary disease.At study inclusion, the 100% occluded target lesion was 280mm in length in a 5.6mm vessel diameter.The lesion was a little calcified and the vessel was also a little tortuous.Thrombus was present at the proximal, middle and distal portion.Plain old balloon angioplasty (poba) was performed with a 4mmx100mm balloon catheter and the procedure was completed.There was 100% stenosis present after pre-dilatation.The lesion was post-dilated after stent implantation.Anti-platelet therapy was prescribed before, during and after the procedure but the details were unknown.
Additional Manufacturer Narrative
As reported by the (b)(6) smart pms for sfa study, approximately 5 years after two 6x150mm smart stents were implanted in the proximal to the distal portion of the left femoral artery, stent thrombosis was confirmed.The level of abi was 0.34 on the left and pulse of the left popliteal artery was weak.Slight claudication was confirmed as well.Therefore, it was diagnosed as in stent restenosis on the left superficial femoral artery.There was no treatment provided.On the same day, the patient recovered.The event was considered serious, not related to the study devices and the reason of its relevancy judgment was the primary disease.At study inclusion, the 100% occluded target lesion was 280mm in length in a 5.6mm vessel diameter.The lesion was a little calcified and the vessel was also a little tortuous.Thrombus was present at the proximal, middle and distal portion.Plain old balloon angioplasty (poba) was performed with a 4mmx100mm balloon catheter and the procedure was completed.There was 100% stenosis present after pre-dilatation.The lesion was post-dilated after stent implantation.Anti-platelet therapy was prescribed before, during and after the procedure but the details were unknown.The devices remain implanted and are thus not available for evaluation.Device history record reviews were performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Restenosis is associated with the progression of endovascular disease and is a known potential adverse event following stent implantation.Well documented potential complication of stent placement is subsequent intimal hyperplasia and occlusion.Progression of atherosclerosis is an expected outcome of the disease process.Thrombosis is a known potential adverse event associated with stent implantation procedures and is 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 in side of the stent around the damaged areas.Neither the dhr nor the information available for review indicate that there is a design or manufacturing related issue, therefore no corrective action is required.This is one of two devices used in the same patient that were reported to the fda.The associated report number is 9616099-2018-02405.

• Brand Name: SMART 120 150, SFA - 6X150MM
• Common Device Name: SELF EXPANDABLE STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 7897766
• Report Number: 9616099-2018-02404
• Device Sequence Number: 13937302
• Product Code: FGE
• UDI-Device Identifier: 20705032063408
• UDI-Public: 20705032063408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: N/A
• Device Catalogue Number: C06150ML
• Device Lot Number: 15851087
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 38