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

Catalog Number ASC960SJ

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the delivery system was returned inside the procedural sheath; it was not possible to remove the delivery system.The catheter was stretched 44.5cm distal to the strain relief.The overall catheter length was measured at 96.9cm.The distal end of the sheath was partially flared and damaged.The od of the balloon distal cone was measured at 0.105 inch.(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

It was reported that the physician was attempting to use an assurant cobalt stent to treat a severely calcified and tortuous common iliac artery lesion with 99% stenosis.Despite the very severe calcification, pre-dilatation was performed satisfactorily using a scoring balloon catheter.The device was inspected with no issues noted.The device was prepped and negative pressure applied with no issues noted.No difficulties noted during balloon inflation /stent deployment.The device was inflated to about 8atms.It was reported that after the stent was implanted in the target lesion, the stent delivery system was stuck in the sheath port, resistance was noted during the retracting of the device through the sheath and thus could not be removed easily.It is reported that sufficient time was given to the balloon to be deflated prior to attempted removal, but there remains a slight possibility that deflation was incomplete.Leaving the guidewire 0.035" in the patient's body, the stent delivery system was removed out together with the sheath introducer.No damage was noted to the stent.No resistance with ancillary device during delivery or resistance during passing the lesion site reported.No patient 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: 5867908
• MDR Text Key: 51814946
• Report Number: 9612164-2016-00830
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: ASC960SJ
• Device Lot Number: 0007713000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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