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

Catalog Number ASC1060S

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the physician was attempting to use a assurant cobalt stent to a treat a moderately calcified and moderately tortuous common iliac lesion exhibiting 60% stenosis.No damage was noted to the device packaging, and no issues were noted when removing the device from the hoop/tray.The device was prepped with no issues noted.No kinks were noted on the guide catheter or sheath.The lesion was not pre-dilated.During the procedure, the device passed through a previously deployed stent.No resistance was encountered during delivery or excessive force used.No difficulties were noted during balloon inflation/stent deployment.The device was inflated to 9atm.It was reported that difficulties were encountered during balloon deflation and the device would not deflate at the lesion site.After several attempts they were able to remove the delivery system.No stent damage, or intervention was reported as a result of the difficulties experienced.No patient injury reported.

Manufacturer Narrative

Evaluation summary: kinks were visible along the introducer.There were kinks along the catheter distal to the strain relief.The introducer sheath was loaded over the deflated proximal to mid section of the balloon.The exposed distal to mid balloon folds were opened, therefore it was not possible to remove the introducer sheath.Upon pressurisation of the device, a leak was observed on the distal balloon.Upon visual inspection, a cut was observed on the distal balloon material across two balloon folds.The balloon material at the cut site was straight and even.There was no stretching to balloon bond.(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.

• 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: 6057171
• MDR Text Key: 58413289
• Report Number: 9612164-2016-01127
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2017
• Device Catalogue Number: ASC1060S
• Device Lot Number: 0007461263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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