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

Model Number LSMU0800626

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/21/2017

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.Receipt of device is expected.The investigation is currently in progress.

Event Description

It was reported that the stent dislodged in the sheath.During advancement into the lesion, the stent allegedly dislodged from the balloon.Reportedly, the stent remained within the 6fr sheath.There were no issues removing the device from the patient, guidewire access was maintain, and a new device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that the stent dislodged in the 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 left subclavian artery.Access was made via the brachial artery.A 260 rosen guidewire and a cook 6f ansel introducer sheath were used.The patient was being treated for 90% stenosis.During advancement into the lesion, the stent allegedly dislodged from the balloon.Reportedly, the stent remained within the 6fr sheath.The device, stent and sheath were all removed together.There were no issues removing the device from the patient, guidewire access was maintain, and a new device was used to complete the procedure.The stent was protected by the sheath during all steps of tracking too the lesion.Multiple attempts to insert the device into the sheath were not made and the device went into the sheath valve smoothly.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent dislodged in the 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 left subclavian artery.Access was made via the brachial artery.A 260 rosen guidewire and a cook 6f ansel introducer sheath were used.The patient was being treated for 90% stenosis.During advancement into the lesion, the stent allegedly dislodged from the balloon.Reportedly, the stent remained within the 6fr sheath.The device, stent and sheath were all removed together.There were no issues removing the device from the patient, guidewire access was maintained and a new device was used to complete the procedure.The stent was protected by the sheath during all steps of tracking too the lesion.Multiple attempts to insert the device into the sheath were not made and the device went into the sheath valve smoothly.There was no reported patient injury.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.There have been no other complaints reported of any type for this lot number.The device was returned for evaluation.External packaging was returned.No internal packaging was returned.The hub was printed as expected and there were no visual defects noted.The stent guard was not returned.No visual defects were noted on the tip, outer or inner.The stent was not present on the balloon.No visual damage was noted.There were crimp marks on the balloon in the correct position between the two markerbands.A 0.035" guidewire was inserted into the device.The guidewire passed through without any issue.A 6f, 55cm cook sheath was returned with the device.The sheath was bloody.The returned device was inserted with the guidewire into the sheath but travelled approx.15mm past the value.The sheath was cut approx.12mm and 40m from the valve.With difficulty the stent was removed.The result of the investigation is confirmed.The stent was found lodged within the 6f 55cm cook sheath.It should be noted that the event information described that the lesion being treated with the lifestream device was the subclavian artery.This indicates that the device was being used off label.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.Patient factors may also have contributed to the reported event as the stenosis rate was 90%.Based upon the available information a definitive root cause cannot be determined.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated rate for this failure mode is 0.067% (last 24 months) and is hence higher than the predicted rate of 0.01% the rate is decreasing since the process improvement (action from capa) was introduced into production during sept 16.The current rate from sept 16 to nov 17 is 0.02%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 15 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.01% which is equal to the predicted rate the ifu states: a device description 1.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.B 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 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.Air evacuation 7.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.8.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.9.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.10.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.11.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.12.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 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.(b)(4).

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7087475
• MDR Text Key: 94411971
• Report Number: 9616666-2017-00143
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081017
• UDI-Public: (01)05391522081017
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: LSMU0800626
• Device Catalogue Number: LSMU0800626
• Device Lot Number: CMBU0204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR