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

Catalog Number LSM1350726

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/23/2018

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.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that during a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal artery, the balloon expandable vascular covered stent graft allegedly dislodged from the balloon catheter as it was introduced in to the introducer sheath.Reportedly, the device was exchanged for another to continue the procedure.There was no reported patient contact.

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.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the investigation is inconclusive for the reported stent dislodgment issue.The device was not returned for evaluation.The definitive root cause for the reported stent dislodgment issue could not be determined based upon available information.The event description states that the lifestream's intended use was off label i.E.In a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal artery.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries (ifu section b indication for use).It is unknown if there were procedural or handling techniques that contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: the event description states that the lifestream intended use was off label, i.E.To be used in a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal artery.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries (section b indication for use).The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified in common device name and pma/510k.

Event Description

It was reported that during a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal artery, during an unrelated occurrence during the procedure, the health care provider needed to pull back on the introducer sheath and the delivery system together as one unit with the delivery system still in the introducer sheath.It was further reported that the delivery system was then being reintroduce again through the introducer sheath when the stent graft allegedly dislodged from the balloon catheter within the introducer sheath.Therefore, the catheter, the stent graft, and the introducer sheath were removed from the patient successfully.Reportedly, the device was then exchanged for another to complete the procedure.There was no reported patient injury.

• 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: 8180471
• MDR Text Key: 131798867
• Report Number: 9616666-2018-00177
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081550
• UDI-Public: (01)05391522081550
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: LSM1350726
• Device Lot Number: CMCT0459
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1