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

Model Number ASC840SJ

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the delivery system was returned loaded inside an introducer.Blood residue was evident throughout the device.It was not possible to initially remove the delivery system from the introducer sheath.The introducer catheter was kinked.Using mandrel the balloon was successfully removed from the introducer.Negative prep was performed and no leak site noted.The balloon was fully inflated and deflated, with congealed blood evident on the outer surface of the balloon.No deformation was visible to the distal tip.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an assurant cobalt stent to treat a lesion with moderate calcification, moderate tortuosity, 90% stenosis and a length of 30mm, in the iliac artery.There was no unusual resistance encountered when removing the protective sheath.Negative prep was performed.The device was inspected before use, with no issues noted.No resistance was encountered with the ancillary device during delivery.There was no existing stent implanted proximal to the target lesion.The lesion was pre-dilated 3 times at 14 atm for 15 seconds.Inflation and deflation were performed in the lesions multiple times.The percentage lesion stenosis after pre-dilation was 20%.The lesion was approached femorally.No resistance was encountered when passing the lesion.No resistance was encountered during removing the device from the implant site, however, resistance was encountered inside the sheath.When an attempt was made to extract the delivery system, the physician noted that the delivery system was stuck in the sheath.The stent expanded cylindrically and sufficiently along the entire length prior to attempting removal of the balloon.Sufficient time was not given to allow the balloon to fully deflate prior to attempting removal, the device was removed a bit earlier than this.The physician suspected that the issue was as a result of the catheter shaft being kinked.Analysis of the device was requested.A non mdt guidewire and a non mdt sheath were used in the procedure.There was no injury reported.

• 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: 6837288
• MDR Text Key: 85631706
• Report Number: 9612164-2017-01202
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Model Number: ASC840SJ
• Device Catalogue Number: ASC840SJ
• Device Lot Number: 0008377326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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 Age: 82 YR