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

Catalog Number LSM1350537

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

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 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 during a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal artery, after successfully placing one stent graft and flaring the proximal end of the stent graft; after angiography it was identified the stent graft had allegedly migrated slightly causing a slight endoleak.Therefore, another balloon expandable stent graft was used to cover the leak and complete the procedure.There was no reported patient injury.

Event Description

It was reported that during treatment for an advance endovascular aneurysm repair (evar) case in the aorta, renal artery, after the stent graft had been successfully implanted in the patient, and further post dilatation and angioplasty was performed; the health care provider (hcp) identified under fluoroscopy that the stent graft had allegedly moved slightly from the intended location causing a slight alleged endoleak.It was further reported that the hcp stated the endoleak was not life threatening to the patient.Therefore, no further treatment was provided.The patient was stable at the conclusion of the procedure.There was no reported patient injury.

Manufacturer Narrative

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 only complaint that has been reported for this corporate lot number and issue to date.Investigation summary: the result of the investigation is inconclusive for the reported migration issue.The sample was not returned for evaluation.The definitive root cause for the reported migration issue could not be determined based upon available information.The event description states that the lifestream device was being used in a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal 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 (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 states that the lifestream device was being used in a two stent graft placement procedure to treat an advance endovascular aneurysm repair (evar) case in the aorta, renal 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 (section b indication for use).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.

• Brand Name: LIFESTREAM 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: 8182089
• MDR Text Key: 131377085
• Report Number: 9616666-2018-00179
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: LSM1350537
• Device Lot Number: CMCS0454
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1