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

Catalog Number	C06150ML
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6).This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2016-00574 and 9616099-2016-00575.
Event or Problem Description
As reported by the japan smart pms for sfa, after an unspecified time when a 120 150, sfa - 6x150mm smart stent and a 6x100 smart control iliac stent were placed in the middle portion to the distal portion of the femoral artery with unknown stenosis, the periodic survey reported that the following items were entered as "occlusion" on the list; patency, dus, the proximal portion of stenosis psv, and the maximum psv of stenosis.The patient is now under observation, and no treatment was applied.".
Additional Manufacturer Narrative
The product was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2016-00574 and 9616099-2016-00575.
Additional Manufacturer Narrative
Implant date was updated.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2016-00574 and 9616099-2016-00575.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: S.M.A.R.T. NITINOL STENT SYSTEM
• Common Device Name: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• MDR Report Key: 5919399
• Report Number: 9616099-2016-00574
• Device Sequence Number: 599690
• Product Code: FGE
• UDI-Device Identifier: 20705032063408
• UDI-Public: (01)20705032063408(17)150331(10)15851087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2016

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: 03/31/2015
• Device Catalogue Number: C06150ML
• Device Lot Number: 15851087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/31/2016
• Supplement Report FDA Received Date: 09/09/2016; 09/14/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization