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

Model Number LSMU0800837

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a stent placement procedure, the catheter was allegedly found kinked.It was further reported that the stent dislodged.The procedure was completed by using another device.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.Expiry date: 06/2024.Device pending return.

Event Description

It was reported that during preparation of a stent placement procedure, the catheter was allegedly found kinked.It was further reported that the stent dislodged.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

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 this event.Investigation summary: the sample was returned for evaluation.Two pinches were present on the outer of the returned device located 270mm & 290mm from the distal tip.The stent was dislodged over the proximal marker band by 12mm, no evidence of expansion was evident.Heavy blood presence on stent at the proximal end.The result of the investigation is confirmed for the reported stent dislodgment and material deformation issues.The root cause for the reported stent dislodgment and material deformation issue 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: ¿ should excessive resistance be felt at any time during the insertion process, do not force passage.¿ attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.Precautions: ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ do not use if the delivery system cannot be properly flushed.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.¿ this device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.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.Introduction of the endovascular system and placement of the covered stent 13.Advance the endovascular system over the guidewire into the introducer sheath.D4 (expiry date: 06/2024).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.

• 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: 15580064
• MDR Text Key: 302598594
• Report Number: 9616666-2022-00210
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081185
• UDI-Public: (01)05391522081185
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU0800837
• Device Catalogue Number: LSMU0800837
• Device Lot Number: CMFU0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/06/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• 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