MAUDE Adverse Event Report: CORDIS CASHEL SMART CONTROL, ILIAC 6X100; STENT, ILIAC

Catalog Number	C06100SL
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported by the smart pms for sfa study, approximately forty-one months post implantation of a smart (smart control, iliac 6x100) self¿expanding stents (ses) on the superficial femoral artery, the patient had stenosis in the proximal portion of the smart control stent that was confirmed by ankle-brachial index (abi) test, ultrasonogram (us), and computed tomography scan (ct).Then, approximately forty-four months post stent implantation, a balloon dilatation was performed for the stenosis.The next day, the patient recovered and hemodialysis treatment was given.The product was not returned for analysis.A device history record (dhr) review of lot 15672190 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.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.Peripheral revascularization is necessary to reopen an in-stent restenosis caused by neointimal hyperplasia and the ongoing disease process.Neointimal hyperplasia refers to proliferation and migration of vascular smooth muscle cells primarily in the tunica intima, resulting in the thickening of arterial walls and decreased arterial lumen space.Neointimal hyperplasia is the major cause of restenosis after percutaneous interventions such as stenting or angioplasty.The term neointima is used because the cells in the hyperplastic regions of the vascular wall have histological characteristics of both intima and normal artery cells.Neointimal hyperplasia first develops with damage to the arterial wall, followed by platelet aggregation at site of injury, recruitment of inflammatory cells, proliferation and migration of vascular smooth muscle cells, and collagen deposition.Mechanical injury of arteries due to stretching of arterial walls with a balloon catheter results in the recruitment of cells such as monocytes, macrophages, and neutrophils to the site of injury.Macrophages in particular express many growth factors, cytokines, and enzymes that facilitate vascular smooth muscle cell migration and proliferation.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported by the smart pms for sfa study, approximately forty-one months post implantation of a smart (smart control, iliac 6x100) self¿expanding stents (ses) on the superficial femoral artery, the patient had stenosis in the proximal portion of the smart control stent that it was confirmed by ankle-brachial index (abi) test, ultrasonogram (us), and computed tomography scan (ct).Then, approximately forty-four months post stent implantation, a balloon dilatation was performed for the stenosis.The next day, the patient recovered and hemodialysis treatment was given.
Additional Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly.Additional information of the smart pms for sfa study indicated that approximately fifty-nine (59) months post index procedure, the patient had an angiography confirmed that ezr 90% restenosis was in the right common iliac artery and 90% restenosis was the right superficial femoral artery where is the proximal portion from the stent.The patient was recovered by having stents implanted in both lesions.Per the investigator, the event was elated to the index procedure or the study device.As reported by the smart pms for sfa study, approximately forty-one months post implantation of a smart (smart control, iliac 6x100) self¿expanding stent (ses) in the superficial femoral artery, the patient had restenosis in the proximal portion of the smart control stent that was confirmed by ankle-brachial index (abi) test, ultrasonogram (us), and computed tomography scan (ct).Then, approximately forty-four months after the index procedure, a balloon dilatation was performed for the restenosis.The next day, the patient recovered, and hemodialysis treatment was given.Additional information received from the smart pms for sfa study indicated that approximately fifty-nine (59) months post index procedure, the patient had an angiography confirmed 90% restenosis was in the right common iliac artery and 90% restenosis was the right superficial femoral artery in the proximal portion of stent.The patient was treated by having stents implanted in both lesions.Per the investigator, the event was related to the index procedure or the study device.The device was not returned for analysis.A product history record (phr) review of lot 15672190 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent restenosis¿ could not be confirmed as the device was not returned for analysis and procedural films were not received.In-stent restenosis 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 instructions for use (ifu) as such.Peripheral revascularization is necessary to reopen an in-stent restenosis caused by neointimal hyperplasia and the ongoing disease process.Neointimal hyperplasia refers to proliferation and migration of vascular smooth muscle cells primarily in the tunica intima, resulting in the thickening of arterial walls and decreased arterial lumen space.Neointimal hyperplasia is the major cause of restenosis after percutaneous interventions such as stenting or angioplasty.The term neointima is used because the cells in the hyperplastic regions of the vascular wall have histological characteristics of both intima and normal artery cells.Neointimal hyperplasia first develops with damage to the arterial wall, followed by platelet aggregation at site of injury, recruitment of inflammatory cells, proliferation and migration of vascular smooth muscle cells, and collagen deposition.Mechanical injury of arteries due to stretching of arterial walls with a balloon catheter results in the recruitment of cells such as monocytes, macrophages, and neutrophils to the site of injury.Macrophages in particular express many growth factors, cytokines, and enzymes that facilitate vascular smooth muscle cell migration and proliferation.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 6X100
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6955293
• Report Number: 9616099-2017-01514
• Device Sequence Number: 10933496
• Product Code: NIO
• UDI-Device Identifier: 20705032023655
• UDI-Public: 20705032023655
• 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,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 07/31/2013
• Device Catalogue Number: C06100SL
• Device Lot Number: 15672190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 11/28/2018
• 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: GUIDEWIRE 0.014; GUIDING SHEATH 6FR
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 69 YR
• Patient Weight: 47