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

Catalog Number LSM1350737

Device Problem Difficult to Insert (1316)

Patient Problem Stenosis (2263)

Event Date 12/14/2017

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.The investigation is on-going.

Event Description

It was reported that there was restenosis.The complaint device was implanted in the left external iliac artery on (b)(6) 2014.When the device as originally implanted there was difficulty tracking the device through the 6f sheath.Therefore a 7f sheath was used and the procedure was completed successfully.Ultrasound showed a stenosis in the left external iliac artery.Surgical intervention was not required as the patient has no symptoms.The stenosis was assessed as possibly related to the lifestream device.There was no patient injury reported.

Manufacturer Narrative

It was reported that there was restenosis.The complaint device was implanted in the left external iliac artery on (b)(6) 2014.When the device as originally implanted there was difficulty tracking the device through the 6f sheath.Therefore a 7f sheath was used and the procedure was completed successfully.Ultrasound showed a stenosis in the left external iliac artery.It was reported that the patient has occasional symptoms and a focal stenosis (70-80%) in the middle segment of the left external iliac artery.Currently there is no surgical intervention planned.The stenosis was assessed as possibly related to the lifestream device.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 first reported complaint for this lot number and issue to date.The device was not returned for evaluation.The result of the investigation is confirmed.The sample was not returned for evaluation.However while ultrasound confirmed the stenosis and assessed as possibly related to the lifestream device, it was not proven that the device was responsible.Based upon the available information a definitive root cause is unknown.It is also unknown whether patient factors, handling or procedural techniques contributed to the reported event.Based on analysis performed no additional action is required at this time.Finally the complaint rate for the break failure mode is 0.03% and exceeds the predicted rate of 0.01%.Therefore an event has been raised in our quality system to address this issue.The ifu states: 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 restenosis.The complaint device was implanted in the left external iliac artery on (b)(6) 2014.When the device as originally implanted there was difficulty tracking the device through the 6f sheath.Therefore a 7f sheath was used and the procedure was completed successfully.Ultrasound showed a stenosis in the left external iliac artery.It was reported that the patient has occasional symptoms and a focal stenosis (70-80%) in the middle segment of the left external iliac artery.Currently there is no surgical intervention planned.The stenosis was assessed as possibly related to the lifestream device.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: 7133365
• MDR Text Key: 96008597
• Report Number: 9616666-2017-00154
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: LSM1350737
• Device Lot Number: 50114181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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