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

Catalog Number LSM1350537

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

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 evaluation; however, a video was provided for review.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510k number for the lifestream products are identified.(expiry date: 04/2021).

Event Description

It was reported that during a peripheral angioplasty procedure, the stent was allegedly mispositioned.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a peripheral angioplasty procedure, the stent was allegedly mispositioned.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive for the malposition of device issue reported.The video appears to be that of the lower shaft, balloon - stent and distal tip section of a lifestream device.The mp4 file provided shows the hcp move the unexpanded stent freely over the balloon towards the distal tip and back again over the lower section shaft of the device.The definitive root cause for the reported malposition of device issue could not be determined based upon information received from the field communications and mp4 review.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used in a peripheral angioplasty procedure of the right subclavian 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 h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g5.H10: d4 (expiry date: 04/2021),.

• 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: 10592222
• MDR Text Key: 208723803
• Report Number: 9616666-2020-00086
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081413
• UDI-Public: (01)05391522081413
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350537
• Device Lot Number: CMCS0454
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1