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

Catalog Number LSM1351238

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2023).

Event Description

It was reported that stent placement procedure, the stent was pull away at 9f introducer sheath.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 device was returned for evaluation.The investigation is confirmed for the dislodgement issue reported.The stent was returned on the balloon positioned over the proximal markerband.It was dislocated by 5mm towards the proximal bond.The stent was partially expanded at opposite ends although there was no evidence of balloon inflation as the fold and crimp marks were still intact.There was damage noted to the proximal end of the stent.The definitive root cause for the reported dislodgement issue could not be determined based upon information received.Labeling review: 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.H10: b5, d4(expiry date: 01/2023).H11: section a through f - 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 stent placement procedure in the right common iliac artery, the stent dislodged within the 9f introducer sheath as it was been advanced.The procedure was completed 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: 10405999
• MDR Text Key: 203156907
• Report Number: 9616666-2020-00081
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081765
• UDI-Public: (01)05391522081765
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1351238
• Device Lot Number: CMEP0371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89