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

Catalog Number LSM0801238

Device Problem Deflation Problem (1149)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.(expiry date: 08/2023).

Event Description

It was reported that during a stent placement procedure, the stent balloon would not detached.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The result of the investigation is inconclusive for the reported deflation issue.The root cause for the reported deflation issue could not be determined based upon the available information received from the field communications.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 retract the balloon until the balloon is fully deflated under vacuum.15.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.16.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.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: d4 (expiry date: 08/2023), g3, h6 (method) h11: section a through f ¿ the information provide by bd represents all 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 stent placement procedure, the stent balloon would not detached.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: 12164627
• MDR Text Key: 261477245
• Report Number: 9616666-2021-00106
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0801238
• Device Lot Number: CMEW0548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other