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

Catalog Number LSM1350726

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: an evaluation was not performed as the device was not returned.The result of the investigation is inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause cannot be determined.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: 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.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure.Covered stent misplacement during placement procedure.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.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.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.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.The catalog number identified in model #/lot # has not been cleared in the us, but is similar to the lifestream balloon expandable endovascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable endovascular covered stent products are identified in common device name and pma #.(expiry date 04/2021).

Event Description

It was reported that during a fenestrated stent graft procedure in the right renal artery, the balloon expandable covered stent allegedly partially dislodged from the balloon catheter upon repositioning after the introducer sheath was removed.It was further reported that the procedure was completed with the balloon expandable covered stent placed in the intended placement site.Reportedly, there were no leaks identified between the fenestration and covered stent with the final runs, and there was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the result of the investigation is confirmed for the reported stent dislodgment issue.The sample was not returned for evaluation.However review of the two images provided confirmed the dislodged failure mode reported.Image 1 showed an unexpanded stent positioned over the proximal marker band before deployment.The definitive root cause for the reported stent dislodgment issue could not be determined.The sheath used is in accordance with ifu labeling off label use may have contributed to the reported issue.The event description states that the lifestream was being used in a fenestrated stent graft procedure in the right renal artery.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.Procedural techniques may also have contributed to the reported event.The stent allegedly partially dislodged from the balloon catheter upon repositioning after the introducer sheath was removed.It is stated within ifu warnings "the covered stent cannot be repositioned after it is deployed".The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is also unknown if patient factors contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: 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.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure.Covered stent misplacement during placement procedure.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.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.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.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.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable endovascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable endovascular covered stent products are identified.(eval code & desc results 1), the investigation summary has been updated to include an image review.

Event Description

It was reported that during a fenestrated stent graft procedure in the right renal artery, the balloon expandable covered stent allegedly partially dislodged from the balloon catheter upon repositioning after the introducer sheath was removed.It was further reported that the procedure was completed with the balloon expandable covered stent placed in the intended placement site.Reportedly, there were no leaks identified between the fenestration and covered stent with the final runs, and there was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8021793
• MDR Text Key: 126552036
• Report Number: 9616666-2018-00154
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081550
• UDI-Public: (01)05391522081550
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

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 Catalogue Number: LSM1350726
• Device Lot Number: CMCS0271
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/23/2018
• Supplement Dates FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1