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

Model Number LSMU0800938

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a stent placement procedure, the stent allegedly felt resistance upon removing the stent cover.It was further reported that the outer stent was allegedly peeled.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 09/2024).Device pending return.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the lifestream device was returned however the protective sleeve was not returned.The stent exhibited no damage or peeling issues.The result of the investigation is inconclusive for the reported difficult to remove sleeve issue.The result of the investigation is unconfirmed for the reported stent peeling issue.The root cause for the reported difficulty to remove sleeve and stent peeling issues could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event.Indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Warnings: do not use if packaging/pouch is damaged.Use the device prior to the use by date specified on the package.Should excessive resistance be felt at any time during the insertion process, do not force passage.Directions for use: endovascular system preparation.4.Carefully remove the selected device from the package.5.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Potential adverse events: covered stent deformation / kink / fracture.H10: d4 (expiration date: 09/2024).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.H3 other text : see h10.

Event Description

It was reported that during preparation of a stent placement procedure, allegedly there was resistance while removing the protective sleeve from the stent.It was further reported that the outer stent was allegedly peeled.There was no patient contact.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15398842
• MDR Text Key: 301165487
• Report Number: 9616666-2022-00194
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081246
• UDI-Public: (01)05391522081246
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU0800938
• Device Catalogue Number: LSMU0800938
• Device Lot Number: CMFX0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1