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

Catalog Number LSM1350826

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified in section d4 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 510k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.(expiry date 05/2021).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 an endovascular aneurysm repair (evar) procedure, the stent allegedly dislodged from the balloon as it was inserted into the fenestration of the graft and remained in the sheath.It was further reported that the sheath and delivery system were removed from the patient, and an atrium was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this 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 confirmed for the reported stent dislodgment issue.The catheter was not returned, the stent was returned and had not been expanded.The definitive root cause for the reported stent dislodgment issue could not be determined based upon available information from the field communications or the returned sample.It is unknown if patient factors or othe procedural or handling techniques 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 device was being used in an endovascular aneurysm repair (evar) procedure.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.H10: b5; d4 (expiry date 05/2021).

Event Description

It was reported that during an endovascular aneurysm repair (evar) procedure, the healthcare provider (hcp), aware of the off-label indication for use, inserted the delivery system into the fenestration of the graft when the stent allegedly dislodged from the balloon and remained in the sheath.It was further reported that the sheath and delivery system were removed from the patient, and an atrium was used 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 N A ; EI N A
• MDR Report Key: 9365773
• MDR Text Key: 189889627
• Report Number: 9616666-2019-00145
• Device Sequence Number: 1
• Product Code: PRL
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350826
• Device Lot Number: CMCT0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1