MAUDE Adverse Event Report: MEDTRONIC IRELAND ASSURANT COBALT; STENT, ILIAC

Catalog Number	ASC860SV
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was returned to manufacturing facility for analysis.Slight kinks were evident along the catheter of the 8.0mmx60mm delivery system.The balloon returned deflated with crimp impressions visible on the exposed balloon surface.There was no deformation to the distal tip.The still cine images capture the successful deployment of an assurant cobalt 8x30mm and assurant cobalt 8x60mm stent.Foreign material can clearly be seen distal to the assurant cobalt 8x60mm stent.A third assurant cobalt 8x30mm stent is used to jail the foreign material to the vessel wall.
Event or Problem Description
The physician intended to use an assurant cobalt bare metal stent to treat a lesion located in the rt common/external iliac.The lesion reported to be severely calcified, moderately tortuous with 75% stenosis.Calcified stenosis of rt external artery was also noted.Prior to the procedure, the device was inspected with no issues noted.The device was prepped per the ifu and no issues were identified.It was reported that during the procedure, the physician successfully implanted one assurant cobalt (8x30mm ) in the rt ostial iliac, and then when attempting to implant a second assurant cobalt (8x60mm), the physician found a foreign body distal to the stent in the vessel.The physician deployed the second stent, asked for a snare but was never used and then used a third assurance cobalt (8x30mm) stent to jail the foreign body against the arterial wall and ended the case.The physician then requested a mynx closure to close the puncture site.No further clinical sequelae was reported.
Additional Manufacturer Narrative
No foreign material was present on the returned delivery systems.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASSURANT COBALT
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6420128
• Report Number: 9612164-2017-00301
• Device Sequence Number: 18951133
• Product Code: NIO
• UDI-Device Identifier: 00613994931115
• UDI-Public: 00613994931115
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2018
• Device Catalogue Number: ASC860SV
• Device Lot Number: 0008147460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: 07/12/2017; 07/12/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 08/09/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR