MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X100ML; STENT, ILIAC

Catalog Number	C06100ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As reported by the (b)(6) study approximately four years post stent implantation, a restenosis was confirmed by doppler ultrasound (dus) during a follow-up.No treatment was applied.The patient gets follow up examination.The original target lesion, patient¿s vessel level of tortuosity, calcification and the rate of stenosis was unknown.Additional procedural details were requested but are unknown.(b)(4) a review of the manufacturing documentation associated with this lot 15728663 presented no issues during the manufacturing process that can be related to the reported complaint.(b)(4) a review of the manufacturing documentation associated with this lot 15646846 presented no issues during the manufacturing process that can be related to the reported complaint.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.In the literature, in-stent stenosis rates range from 11% to 39% from 6 to 12 months after stent placement.Rates were higher in older patients with more severe atherosclerosis and depended on the type of stenosis treated.Isr is more prevalent in ostial stent placement procedures.Stenoses in stents are usually treated with intra-stent pta or placement of a second stent.Factors that may have influenced this event include patient, procedural, pharmacological and lesion.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported by the (b)(6) study approximately four years post stent implantation, a restenosis was confirmed by doppler ultrasound (dus) during a follow-up.No treatment was applied.The patient gets follow up examination.The original target lesion, patient¿s vessel level of tortuosity, calcification and the rate of stenosis was unknown.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 6X100ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6801919
• Report Number: 9616099-2017-01332
• Device Sequence Number: 11013670
• Product Code: NIO
• UDI-Device Identifier: 20705032023624
• UDI-Public: 20705032023624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 09/30/2014
• Device Catalogue Number: C06100ML
• Device Lot Number: 15728663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/17/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 65