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

Model Number LSMU1350816

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

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.(expiry date 04/2020).

Event Description

It was reported during treatment of the slightly calcific right renal artery via right groin access, the healthcare provider (hcp) advanced the delivery system to the lesion, began inflating the balloon to 8 atm, and then ceased inflation as the introducer sheath may have been covering the proximal end of the stent graft.As a result, the hcp pulled the delivery system back into the introducer sheath and the stent graft allegedly dislodged 30 cm into the sheath.It was further reported that a pta balloon was deployed to nominal pressure within the stent inside the introducer sheath and the delivery system was withdrawn through the introducer sheath.Reportedly, another stent graft was used to complete the procedure through the same access site.There was no reported patient injury.

Event Description

It was reported that during treatment of the slightly calcific right renal artery via right groin access, the healthcare provider (hcp), aware of the off-label indication for use, advanced the delivery system to the lesion and inflated the balloon to 8 atm, and then realized the introducer sheath may have been covering the proximal end of the stent graft.Therefore, the balloon was deflated and upon retracting the delivery system, the device allegedly caught on the stent graft and pulled it back into the introducer sheath causing it to allegedly dislodge 30cm.It was further reported that the hcp used another manufacturer's pta catheter and inflated it inside the stent graft, successfully removed it thought the introducer sheath.Reportedly, another delivery systems was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the investigation is inconclusive for the reported stent dislodgment and retraction issues.The sample was not returned for evaluation.Off label use and user errors were likely factors that contributed to the reported event.The event description states that the lifestream was being used in the renal artery.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.After placement of the stent and inflation of the balloon the proximal end of the stent was covered by the sheath.Following this the balloon was deflated and the stent pulled back into the sheath causing it to dislodge.This is contrary to what is directed in the ifu which states "attempts to retract the covered stent into the sheath/guiding catheter may result in the stent dislodgment".Finally the patient conditions of a slightly calcific right renal artery may have attributed to the reported event.The definitive root cause for the reported stent dislodgment and retraction issues could not be determined based upon available information.Labeling review: 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.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.

• 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 N A ; EI N A
• MDR Report Key: 8960660
• MDR Text Key: 156592126
• Report Number: 9616666-2019-00096
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081628
• UDI-Public: (01)05391522081628
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350816
• Device Catalogue Number: LSMU1350816
• Device Lot Number: CMBS0393
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1