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

Catalog Number ASC1030SV

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/09/2014

Event Type  Injury  

Event Description

An assurant cobalt peripheral stent system was being used to treat a lesion.The lesion was moderately calcified and moderately tortuous.The device was removed from the packaging with no issues noted.Device was inspected prior to use with no issues noted.The assurant cobalt stent was being deployed within an occluded stent.It is reported that during stent deployment the balloon burst.The burst was rapid.The balloon was only inflated once.The device was removed from the patient without issue, however on removal the doctor noticed that the balloon was not on the end of the shaft.A x-ray was completed and the radioapaque markers were seen in the 7fr access sheath.The shaft had detached at the proximal end of the balloon.The doctor had to cut down the vessel to remove the sheath and the shaft as one unit.The patient has several extra stitches and some bleeding as a result of this event.No additional clinical sequelae were reported.

Manufacturer Narrative

Evaluation, results: patient¿s condition affected effectiveness of device (moderately calcified and moderately tortuous), (no results available since no evaluation performed - device or procedural images not provided for review), related to operational context (dialysis fistula and previous interventions impacted on procedure), (device not returned); conclusion, results: device failure/lack of effectiveness related to patient condition (moderately calcified and moderately tortuous), unable to confirm complaint (device or procedural images not provided for review), related to operational context (dialysis fistula and previous interventions impacted on procedure), device not returned - no evaluation could be performed.(b)(4).

Manufacturer Narrative

Results: device not approved for use in the arm, balloon.Conclusion: device not approved for use in the arm.

Event Description

Device evaluation: device returned with distal inner shaft detached from device.Detached section returned on access sheath.There was a jagged tear along working length of balloon.Distal inner shaft stretched on access sheath.Distal and proximal marker bands present with proximal marker band loose on access sheath.Detachment points on proximal shaft and distal inner shaft jagged and show signs of stretching.Distal section of balloon attached to distal inner shaft with proximal section detached from inner shaft with tears evident along the proximal cone.

• 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: 4349282
• MDR Text Key: 5176874
• Report Number: 9612164-2014-01721
• Device Sequence Number: 1
• Product Code: NIO
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2015
• Device Catalogue Number: ASC1030SV
• Device Lot Number: 0006963577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• 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