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

Catalog Number LSM1350737

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Death (1802); Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199); Pseudoaneurysm (2605)

Event Date 10/10/2018

Event Type  Death  

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 inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that after the stent graft was deployed to cover a pseudo aneurysm, the lesion developed a leak as the device allegedly did not seal.Reportedly, an additional stent graft was deployed to seal the lesion, stop the leak, and successfully complete the procedure.There was no reported patient injury.

Event Description

It was reported that after the stent graft was deployed in the common femoral artery to cover a pseudo aneurysm, the lesion developed a leak as the device allegedly did not seal and an alleged vessel perforation was identified.Reportedly, an additional stent graft was deployed to seal the lesion, stop the leak, and successfully complete the procedure.However, the patient expired a couple of hours post procedure.The patient¿s cause of death was not provided, and no other pertinent patient, device or medical information was provided leading up to or surrounding the event.

Manufacturer Narrative

New information provided changed the mdr date of awareness from 10/16/2018 (originally reported in the i/f mdr) to 10/10/2018.Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the first reported complaint for this lot number and issue to date.Investigation summary: the result of the investigation is confirmed for the reported lesion leak issue.The sample was not returned for evaluation.The definitive root cause for the reported lesion leak issue could not be determined based upon available information.The event description outlines that the stent was deployed in the common femoral artery to cover a pseudo aneurysm.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.(section b indication for use).Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: the event description outlines that the stent was deployed in the common femoral artery to cover a pseudo aneurysm.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.

• Brand Name: LIFSTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8061073
• MDR Text Key: 127865253
• Report Number: 9616666-2018-00159
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: LSM1350737
• Device Lot Number: CMBV0152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR