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

Model Number LSMU1350526

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

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

Event Date 11/27/2021

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the device allegedly stuck inside the sheath upon insertion.The procedure was completed by accessing from the other side.There was no reported patient injury.

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.

Event Description

It was reported that during an angioplasty procedure, the device allegedly stuck inside the sheath upon insertion.The procedure was completed by accessing from the other side.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the lifestream device was returned without the stent present on the balloon.The balloon had not been inflated, the pleats, folds and stent crimp marks were still intact.The evaluation confirmed a dislodgement issue.The stent was located lodged within the returned 6fr cook sheath at the entrance of the hemostatis valve.The result of the investigation is inconclusive for the reported device incompatibility issue.The root cause for the reported device incompatibility issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: directions for use.Site access and preparation.1.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection.3.Select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.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.Introduction of the endovascular system and placement of the covered stent 13.Advance the endovascular system over the guidewire into the introducer sheath.14.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath / guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.H10: d4 (expiry date: 09/2024), g3, h6 (device).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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13085499
• MDR Text Key: 284642684
• Report Number: 9616666-2021-00237
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522080980
• UDI-Public: (01)05391522080980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350526
• Device Catalogue Number: LSMU1350526
• Device Lot Number: CMFX0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• 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