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

Catalog Number LSMU1350716

Device Problems Entrapment of Device (1212); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 07/21/2017

Event Type  Injury  

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 during an attempt to reposition the stent, the stent dislocated.There were no anomalies noted during the rep 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 celiac artery.The patient was being treated for stenosis of the celiac and sma.The rate of stenosis was greater than 50%.The lesion was tortuous.A 6fr 65 cm terumo destination introducer sheath and a cook rosen 260 cm.035 in guidewire were used.The device was inserted.Reportedly resistance was felt at the valve of the sheath and minimally throughout the length of the sheath.Tracking through the lesion into the celiac was calcified.During an attempt to reposition the stent, the stent allegedly got caught on the introducer sheath and dislocated from the balloon.The stent was inside the patient and an attempt was being made to pull the device back into the sheath when the stent dislocated.The reason for pulling the device into the sheath was that the patient had moved and then required another angiogram for repositioning.The stent was then recaptured with a 4 mm angioplasty balloon and pulled to the external iliac artery where it was expanded and implanted without incident.Access was lost and after the stent was recaptured and deployed the physician recannulated the vessel.There was no reported difficulty in removing the delivery system from the patient.The stent was protected until the length of the sheath.A 90 cm sheath was not available.Pre-dilatation was not performed.Air evacuation was performed prior to inserting the device.Multiple attempts to insert the device into the sheath were not required.There was no reported patient injury.

Manufacturer Narrative

It was reported that during an attempt to reposition the stent, the stent dislocated.There were no anomalies noted during the rep 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 celiac artery.The patient was being treated for stenosis of the celiac and sma.The rate of stenosis was greater than 50%.The lesion was tortuous.A 6fr 65cm terumo destination introducer sheath and a cook rosen 260cm.035in guidewire were used.The device was inserted.Reportedly resistance was felt at the valve of the sheath and minimally throughout the length of the sheath.Tracking through the lesion into the celiac was calcified.During an attempt to reposition the stent, the stent allegedly got caught on the introducer sheath and dislocated from the balloon.The stent was inside the patient and an attempt was being made to pull the device back into the sheath when the stent dislocated.The reason for pulling the device into the sheath was that the patient had moved and then required another angiogram for repositioning.The stent was then recaptured with a 4mm angioplasty balloon and pulled to the external iliac artery where it was expanded and implanted without incident.Access was lost and after the stent was recaptured and deployed the physician recannulated the vessel.There was no reported difficulty in removing the delivery system from the patient.The stent was protected until the length of the sheath.A 90cm sheath was not available.Pre-dilatation was not performed.Air evacuation was performed prior to inserting the device.Multiple attempts to insert the device into the sheath were not required.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.The device was not returned for evaluation.The result of the investigation is inconclusive as no sample was returned for evaluation.The event describes that the lifestream device was used off label and user error was also involved.The device was being used in a celiac artery.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries as per the ifu.The patient conditions may also have contributed to the issue as the rate of stenosis was greater than 50% and the lesion was tortuous.Tracking through the lesion into the celiac was calcified.The event description also detailed that the stent dislocated when device was pulled back into the sheath.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated rate for this failure mode is 0.077% (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 oct 16 to july 17 is 0.01%.This is equal to the predicted rate of 0.01%.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).

• 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: 6797417
• MDR Text Key: 82789972
• Report Number: 9616666-2017-00061
• Device Sequence Number: 1
• Product Code: PRL
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: LSMU1350716
• Device Lot Number: CMBS0155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR