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

Catalog Number	ASC960SV
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device returned loaded in the introducer sheath.It was not possible to remove the device from the introducer sheath.Blood was visible in the introducer sheath.Deformation was evident to the stent segments with the struts appearing stretched and raised.The stent was stretched with the 1st distal segment positioned over the distal markerband.There was no deformation evident to the distal tip.There was no deformation evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the assurant cobalt to treat a moderately calcified cto in the common iliac artery.Prepped as per ifu with no issues noted.No difficulty was encountered when tracking the vessel.It was reported the physician encountered resistance when advancing the device, no excessive force was used.The assurant cobalt device remained stuck in the sheath.Both were removed in tandem.The procedure was completed by removing the sheath.No injury to the patient was reported.

• Brand Name: ASSURANT COBALT
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8173497
• Report Number: 9612164-2018-03679
• Device Sequence Number: 13814655
• Product Code: NIO
• UDI-Device Identifier: 00613994931153
• UDI-Public: 00613994931153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: ASC960SV
• Device Lot Number: 0008201366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1