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

Catalog Number LSM1350637

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device is not expected to be returned.The investigation is on-going.

Event Description

It was reported that there was high friction when advancing the device through the 6f sheath.The sheath used was a 6f cook flexor tuohy borst side arm introducer sheath and a check flo hemostasis assembly to deploy the stent.There was very big friction when attempting to advance the device into the introducer sheath and then the guidewire became damaged.The procedure was a kissing stent procedure in a 6 mm vessel.There was no patient injury reported.

Manufacturer Narrative

It was reported that there was high friction when advancing the device through the 6f sheath.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and there was no difficulty removing the stent cover.The target lesion was the gluteal artery and the patient was being treated for a leakage.A contralateral approach was made.The sheath used was a 6f cook flexor tuohy borst side arm introducer sheath and a check flo hemostasis assembly to deploy the stent.There was very big friction when attempting to advance the device through the introducer sheath and then the guidewire became damaged.The procedure was completed and the stent was implanted.The procedure was a kissing stent procedure in a 6mm vessel.Air evacuation was performed prior to inserting the device into the sheath.The implant was not lodged within the sheath throughout the tracking procedure.Guidewire access was maintained throughout the procedure.The delivery system was not pulled back into the sheath at any time during the procedure.There was no patient injury reported.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the second reported complaint for this lot number and issue to date.The device was not returned for evaluation.The result of the investigation is inconclusive as no sample returned for evaluation.Based upon the available information and sample evaluation a definitive root cause has not been determined.Based on analysis performed no additional action is required at this time.A capa has raised to address device - device incompatibility issues which have been reported.The ifu states: a device description: implant the lifestream¿ balloon expandable vascular covered stent is comprised of an electropolished balloon-expandable stent made from 316l stainless steel, encapsulated between two layers of eptfe.Indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Directions for use: site access and preparation 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.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection 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 carefully remove the selected device from the package.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.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation a 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.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.(b)(4).

Event Description

It was reported that there was high friction when advancing the device through the 6f sheath.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and there was no difficulty removing the stent cover.The target lesion was the gluteal artery and the patient was being treated for a leakage.A contralateral approach was made.The sheath used was a 6f cook flexor tuohy borst side arm introducer sheath and a check flo hemostasis assembly to deploy the stent.There was very big friction when attempting to advance the device through the introducer sheath and then the guidewire became damaged.The procedure was completed and the stent was implanted.The procedure was a kissing stent procedure in a 6mm vessel.Air evacuation was performed prior to inserting the device into the sheath.The implant was not lodged within the sheath throughout the tracking procedure.Guidewire access was maintained throughout the procedure.The delivery system was not pulled back into the sheath at any time during the procedure.There was no patient injury reported.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 6720838
• MDR Text Key: 80511664
• Report Number: 9616666-2017-00057
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: LSM1350637
• Device Lot Number: 50137142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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