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

Catalog Number LSM0801238

Device Problem Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 06/05/2020

Event Type  Injury  

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.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.(expiration date: 08/2022).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 graft procedure, the stent allegedly stuck in the patient.It was further reported that the stent could not be retrieved and placed with another bare stent.There was no reported patient status.

Event Description

It was reported that during a stent graft procedure, the stent allegedly stuck in the patient.It was further reported that the stent was uncrimping at the end of the arterial introducer.Reportedly the stent could not be retrieved and placed with another bare stent.The current patient status was unknown.

Manufacturer Narrative

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: 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; therefore, the investigation is inconclusive for the reported stent stuck in patient issue.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: covered stent dislodgement from balloon during tracking procedure.Covered stent misplacement during placement procedure.Covered stent migration post placement procedure.Inability to introduce/withdraw endovascular system.Inability to track endovascular system to the target lesion.H10: d4 (expiration date: 08/2022).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
• 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: 10210955
• MDR Text Key: 196937820
• Report Number: 9616666-2020-00044
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081741
• UDI-Public: (01)05391522081741
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0801238
• Device Lot Number: CMDW0325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention