MAUDE Adverse Event Report: CORDIS CASHEL SMART CONTROL, ILIAC 6X60ML; STENT, ILIAC

Catalog Number C06060ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Multiple Organ Failure (3261)

Event Date 02/06/2017

Event Type  Death  

Manufacturer Narrative

As reported by the smart pms for sfa study, approximately forty months post implantation of a smart (smart control, iliac 6x60ml) self¿expanding stents (ses) on the superficial femoral artery (sfa), the patient went to a different hospital for dialysis.However, during dialysis, the patient expired.The cause of death was multiple organ failure.None of these events were relevant to the index procedure or the cordis product.Originally, the patient had been implanted with a smart stent that was deployed in the target lesion without any issue.The device was not returned for evaluation.A review of the manufacturing documentation associated with lot 15647816 presented no issues during the manufacturing process that can be related to the reported event.Death is a known potential adverse event associated with stent implantation procedures and is listed in the instructions for use (ifu), which are not intended as mitigation, as such.All products undergo a 100% inspection prior to release for marketing.Intra-arterial stent placement is a treatment of the disease process and it not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.A review of the available information does not allow for an exact determination of causal factors.However, based on the information provided, the root cause for the reported events was attributed to multiple organ failure.Given the limited information available for review at this time, 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 Description

As reported by the smart pms for sfa study, approximately forty months post implantation of a smart (smart control, iliac 6x60ml) self¿expanding stents (ses) on the superficial femoral artery, the patient went to a different hospital for dialysis.However, during dialysis, the patient expired.The cause of death was multiple organ failure.None of these events were relevant to the index procedure or the cordis product.A smart stents was deployed in the target lesion without any issue.

• Brand Name: SMART CONTROL, ILIAC 6X60ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6902014
• MDR Text Key: 87672709
• Report Number: 9616099-2017-01473
• 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,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: C06060ML
• Device Lot Number: 15647816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.014; GUIDING SHEATH: 6FR; SHEATH INTRODUCER: 6FR
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 70