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

Catalog Number LSM1350737

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).

Event Description

It was reported that during the procedure, the stent allegedly dislodged from the balloon.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the lifestream device was not returned.An image of a device was provided.An object likely a stent is visible separate to the balloon.Due to poor resolution of the image it cannot be determined if the balloon had been inflated and if the stent had been expanded.The result of the investigation is confirmed for the reported dislodgement issue.The root cause for the reported dislodgement issue could not be determined based upon the available information.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings: ¿ do not use if packaging/pouch is damaged.¿ attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.¿ use only diluted contrast medium for balloon inflation.Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent.For the contrast/saline solution, a ratio of 50/50 is recommended.Precautions ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.¿ store in a cool and dry place.Keep away from sunlight.Covered stent size selection 3.Select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.H10: d4 (expiry date: 06/2023).

Event Description

It was reported that during the procedure, the stent allegedly dislodged from the balloon.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: LIFESTREAM
• 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: 12478958
• MDR Text Key: 271654367
• Report Number: 9616666-2021-00144
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081567
• UDI-Public: (01)05391522081567
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350737
• Device Lot Number: CMEU0184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1