MAUDE Adverse Event Report: CORDIS DE MEXICO SMART 120 150, SFA - 7X150MM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	C07150ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Reocclusion (1985); Vascular System (Circulation), Impaired (2572)
Date of Event	06/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was implanted in the target lesion without any issue.The patient was a (b)(6) female.The patient¿s weight was (b)(6).The original target lesion was the middle portion of the right femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.Approximately 3 years after the index procedure, the patient had pain.A month later the patient underwent a radiography which confirmed that the lesion had residual stenosis.Therefore the patient underwent a percutaneous transluminal angioplasty (pta) and an unknown stent was implanted in the entry of the superficial femoral artery.The patient recovered.The event was determined to have no relevancy with the product or the index procedure.The device was not returned for evaluation as it remains implanted.A review of the manufacturing documentation associated with lot 15844403 presented no issues during the manufacturing process that can be related to the reported event.Without the return of the device for analysis or procedural films, the reported event could not be confirmed and the exact cause could not be determined.However, given the limited information available for review, patient, lesion and/or pharmacological factors may have contributed to the reported event.Restenosis and occlusion are known potential adverse events associated with implanting stents.Restenosis is often associated with the progression of artery disease.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 and instigate vessel remodeling around the stent, producing gaps between the stent and the vessel wall.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, the patient was implanted with a smart stent in the target lesion without any issue.The patient was a (b)(6) female.The patient¿s weight was (b)(6).The original target lesion was the middle portion of the right femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.Approximately 3 years after the index procedure, the patient had pain.A month later the patient underwent a radiography which confirmed that the lesion had residual stenosis.Therefore the patient underwent a percutaneous transluminal angioplasty (pta) and an unknown stent was implanted in the entry of the superficial femoral artery.The patient recovered.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6774421
• Report Number: 9616099-2017-01309
• Device Sequence Number: 1246501
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• 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: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: C07150ML
• Device Lot Number: 15844403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/08/2017
• 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: 75 YR
• Patient Weight: 56