MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT

Catalog Number LSM0800626

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during a stent graft deployment procedure, the balloon expandable vascular stent graft allegedly dislodged from the balloon.Another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a stent graft deployment procedure for a fenestrated evar in the renal artery, the balloon expandable vascular stent graft allegedly dislodged from the balloon as the catheter was pulled back slightly when positioning the stent graft within the fenestration.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The result of the investigation is inconclusive for the reported stent dislodgment issue.The sample was not returned for evaluation.Off label use and procedural techniques may have contributed to the reported issue.The event description states that the lifestream was being used in the renal artery in a fenestrated evar case.The doctor responsible was aware of the off label use.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.The event description also details that during positioning of the lifestream within the fenestration the user had to pull back on the catheter slightly.The stent dislodged from the balloon during this movement.This is contrary to what is directed in the ifu.Indication for use states "attempts to retract the covered stent into the sheath/guiding catheter may result in the stent dislodgment".The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.The definitive root cause for the reported stent dislodgment issue could not be determined.The ifu for the lifestream product was reviewed for information relevant to the reported event: the event description states that the lifestream was being used in the renal artery in a fenestrated evar case.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.(expiry date 05/2021).

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7993750
• MDR Text Key: 126081382
• Report Number: 9616666-2018-00147
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081437
• UDI-Public: (01)05391522081437
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0800626
• Device Lot Number: CMCT0353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1