MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (NIO)

Catalog Number C07060SL

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Thrombosis (2100); Tissue Damage (2104)

Event Date 08/08/2014

Event Type  Injury  

Event Description

The report received from the affiliate indicated that the patient was enrolled in a clinical study (b)(4) smart pms for sfa (superficial femoral artery).During the study index procedure a smart control 7 x 60 stent was implanted in the target lesion without any issue.Two days after the index procedure, thrombus in the stent was noted.Three days later, the occlusion was treated by percutaneous transluminal angioplasty (pta) and the patient partially recovered.Thirteen days after the index procedure, the thrombosis in the stent was treated by pta and the patient partially recovered.Thirty two days after the index procedure, re-occlusion of the lesion was observed and surgical amputation of leg above the knee was conducted.Three months after the amputation, the flow was rebuilt with a synthetic graft.Fifty-one days after the index procedure, the patient developed pneumonia (acute exacerbations of copd).Approximately seven months after the index procedure, with medication and surgical operation, the patient was outcome to partially recover and the patient was transferred to a different hospital.Later the same month after transfer to the other hospital, the patient experienced redness at the lesion.Approximately eight months after the index procedure, the patient had a fever due to the flu and expired fifteen days later due to the flu.Additional information has been requested.

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance 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.

Manufacturer Narrative

As reported, the patient was enrolled in a (b)(4) study (b)(4).During the study index procedure a smart control 7 x 60 stent was implanted in the target lesion without any issue.Two days after the index procedure, thrombus in the stent was noted.Three days later, the occlusion was treated by percutaneous transluminal angioplasty (pta) and the patient partially recovered.Thirteen days after the index procedure, the thrombosis in the stent was treated by pta and the patient partially recovered.Thirty two days after the index procedure, re-occlusion of the lesion was observed and surgical amputation of leg above the knee was conducted.Three months after the amputation, the flow was rebuilt with a synthetic graft.Fifty-one days after the index procedure, the patient developed pneumonia (acute exacerbations of copd).Approximately seven months after the index procedure, with medication and surgical operation, the patient was outcome to partially recover and the patient was transferred to a different hospital.Later the same month after transfer to the other hospital, the patient experienced redness at the lesion.Approximately eight months after the index procedure, the patient had a fever due to the flu and expired fifteen days later due to the flu.Multiple attempts to obtain additional information were unsuccessful.The product was not returned for analysis.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Based on the information provided and the inability to assign or determine a root cause, no corrective actions will be taken at this time.Thrombosis and restenosis are known complications of patients with peripheral vascular disease who have undergone percutaneous intervention and are captured in the instructions for use (ifu) as such.There are possible patient, vessel/lesion, and pharmacological factors that may have contributed to the reported events.Based on the minimal available information there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4096780
• MDR Text Key: 17263533
• Report Number: 9616099-2014-00597
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: C07060SL
• Device Lot Number: 15687660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR