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

Catalog Number ASC860SV

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/21/2017

Event Type  Injury  

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 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASSURANT COBALT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6420128
• MDR Text Key: 70408283
• Report Number: 9612164-2017-00301
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00613994931115
• UDI-Public: 00613994931115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR