MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE OTW NITINOL SYS, 9X40; STENT, CAROTID

Catalog Number	P09040XC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and is thus not available for analysis.A review of the manufacturing documentation associated with lot 17337069 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, an arterial perforation was noted at the distal edge of a precise over the wire (otw) nitinol sys, 9x40 stent.Initially the physician had deployed the stent with no issues.The stent was post dilated with an aviator.After the perforation was noted, a second precise stent (9x40) was placed and overlapped.The stents were post dilated with non-cordis balloons and the perforation appeared to have resolved.
Additional Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly.As reported, an arterial perforation was noted at the distal edge of a precise over the wire (otw) nitinol sys, 9x40 stent.The lesion was mildly calcified and had moderate vessel tortuosity.The rate of stenosis was more than 60%.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu and prepped normally.There was no difficulty tracking the stent deployment system through the lesion and there was no difficulty crossing the lesion.Initially the physician had deployed the stent with no issues.The stent was post dilated with an aviator.After the perforation was noted, a second precise stent (9x40) was placed and overlapped.The stents were post dilated with non-cordis balloons and the perforation appeared to have resolved.The patient¿s status is baseline.Additional procedural details were requested but are unknown.As reported, an arterial perforation was noted at the distal edge of a precise over the wire (otw) nitinol sys, 9x40 stent.The lesion was mildly calcified and had moderate vessel tortuosity.The rate of stenosis was more than 60%.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu and prepped normally.There was no difficulty tracking the stent deployment system through the lesion and there was no difficulty crossing the lesion.Initially the physician had deployed the stent with no issues.The stent was post dilated with an aviator.After the perforation was noted, a second precise stent (9x40) was placed and overlapped.The stents were post dilated with non-cordis balloons and the perforation appeared to have resolved.The patient¿s status is baseline.Additional procedural details were requested but are unknown.The device was not returned for evaluation as it remains implanted.A review of the manufacturing documentation associated with lot 17337069 presented no issues during the manufacturing process that can be related to the reported event.Without procedural films for review, the reported perforation could not be confirmed and a clinical conclusion could not be determined as to the cause of the event.However, based on the available information, vessel characteristics and/or procedural factors may have contributed to the reported event.Usage of the product other than that indicated in the product's ifu, which is not intended as mitigation, may involve additional risks not described in the labeling.Vessel injury is a well-known complication of stent implantation.According to the ifu, ¿upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the vessel.Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent¿.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.

• Brand Name: PRECISE OTW NITINOL SYS, 9X40
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6824697
• Report Number: 9616099-2017-01365
• Device Sequence Number: 1313125
• Product Code: NIM
• UDI-Device Identifier: 20705032035573
• UDI-Public: 20705032035573
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 08/31/2017
• Device Catalogue Number: P09040XC
• Device Lot Number: 17337069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVIATOR 6X4; MUSTANG 5X4; MUSTANG 6X4; PRECISE 9X40
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention