MAUDE Adverse Event Report: CORDIS CORPORATION S.M.A.R.T. NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C07120ML

Device Problem Insufficient Information (3190)

Patient Problem Claudication (2550)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the patient was enrolled in a clinical study (b)(6) for (b)(6) and the case number is (b)(6).Nineteen months post stenting of a smart stent to an unknown lesion ((b)(6) 2015), the patient suffered intermittent claudication of inferior limb.The abi, arteriography and target vessel revascularization was performed on (b)(6) 2015.The patient recovered.The smart stent was placed in (b)(6) 2013 without any issues.At the index procedure, the rate of stenosis was 90%.

Manufacturer Narrative

Complaint conclusion: as reported, the patient was enrolled in a clinical study (b)(4) and the case number is (b)(6).Nineteen months post stenting of a smart stent to an unknown lesion ((b)(6) 2015), the patient suffered intermittent claudication of inferior limb.The abi, arteriography and target vessel revascularization was performed on (b)(6) 2015.The patient recovered.The smart stent was placed in (b)(6) 2013 without any issues.At the index procedure, the rate of stenosis was 90%.The patient¿s medical history is unknown.No additional information is available.The product remains implanted in the patient and thus is not available for evaluation.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.In-stent restenosis is a well-known potential complication for this type of procedural and it listed in the ifu.In the literature, in-stent stenosis rates from 11% to 39% from 6 to 12 months after the stent placement.Rates are higher in older patient with more severe atherosclerosis and depended on the type of stenosis treated.Stenosis in stents are usually treated with intrastent pta or placement of a second stent.Progression of atherosclerotic disease is known to cause instent restenosis and does not indicate a device failure.Intra-arterial stent placement is a treatment of the disease process and it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.There is no evidence of manufacturing issues that may have contributed to the reported event therefore; no corrective action is required at this time.

• Brand Name: S.M.A.R.T. NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5162562
• MDR Text Key: 28815970
• Report Number: 9616099-2015-00505
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: C07120ML
• Device Lot Number: 15849815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR