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

Catalog Number LSM1350637

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent graft products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent graft products are identified.(expiry date: 03/2019).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.

Event Description

It was reported that there was alleged difficulty advancing the 6x37 balloon expandable vascular covered stent graft device through a 6fr introducer sheath.The procedure was an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma).The device was passed through a hemostatic valve before going through a 6fr introducer sheath via the right groin into the aorta.The device was loaded over an 0.035" guidewire and into the sheath.Reportedly, there was alleged tightness felt, however, a decision was made to continue loading the 6x37 balloon expandable vascular covered stent graft device through the introducer sheath.It was further reported that due to the tightness it was slower to advance the device through the introducer sheath, and that prior to reaching the target lesion a decision was made to remove the device, and use a 5mm stent graft instead.The 6x37 balloon expandable vascular covered stent graft device was then removed from the patient without incident.Reportedly, a 5x37 balloon expandable vascular covered stent graft device was then used and successfully placed in the patient although with alleged difficulty during advancement through the sheath.Furthermore, during the deflation process and advancement of the introducer sheath back over the balloon the sheath allegedly caught on the 5x37 stent graft pushing it distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to again bareback this 6x37 balloon expandable vascular covered stent graft device to place it into the 5x37 stent graft.This 6x37 device was then advanced to the target lesion without any dislodgement however it failed to sit inside the 5x37 stent graft as intended and instead pushed it a little farther into the artery.The 5x37 stent was now covering a branch and thrombus.Therefore, this 6x37 device was not deployed and removed without incident from the patient, and the procedure was completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 stent graft on the left renal.A 12x37 delivery system was also deployed in the sma without further incident.There was no reported patient injury.

Event Description

It was reported that there was alleged difficulty advancing the 6x37 balloon expandable vascular covered stent graft device through a 6fr introducer sheath.The procedure was an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma).The device was passed through a hemostatic valve before going through a 6fr introducer sheath via the right groin into the aorta.The device was loaded over an 0.035" guidewire and into the sheath.Reportedly, there was alleged tightness felt, however, a decision was made to continue loading the 6x37 balloon expandable vascular covered stent graft device through the introducer sheath.It was further reported that due to the tightness it was slower to advance the device through the introducer sheath, and that prior to reaching the target lesion a decision was made to remove the device, and use a 5mm stent graft instead.The 6x37 balloon expandable vascular covered stent graft device was then removed from the patient without incident.Reportedly, a 5x37 balloon expandable vascular covered stent graft device was then used and successfully placed in the patient although with alleged difficulty during advancement through the sheath.Furthermore, during the deflation process and advancement of the introducer sheath back over the balloon the sheath allegedly caught on the 5x37 stent graft pushing it distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to again bareback this 6x37 balloon expandable vascular covered stent graft device to place it into the 5x37 stent graft.This 6x37 device was then advanced to the target lesion without any dislodgement however it failed to sit inside the 5x37 stent graft as intended and instead pushed it a little farther into the artery.The 5x37 stent was now covering a branch and thrombus.Therefore, this 6x37 device was not deployed and removed without incident from the patient, and the procedure was completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 stent graft on the left renal.A 12x37 delivery system was also deployed in the sma without further incident.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.Investigation summary: the investigation was confirmed for the reported device incompatibility failure mode.During the functional evaluation of the returned device significant resistance was encountered as the catheter was fed through the 6f sheath but, the device passed through successfully.The stent was slightly bowed in the midsection and this was the likely contributory factor in the reported event.However, based on the available information a definitive root cause has not been determined.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: 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.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 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.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.Updated investigation summary section.

Event Description

It was reported that there was alleged difficulty advancing the 6x37 balloon expandable vascular covered stent graft device through a 6fr introducer sheath.The procedure was an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma).The device was passed through a hemostatic valve before going through a 6fr introducer sheath via the right groin into the aorta.The device was loaded over an 0.035" guidewire and into the sheath.Reportedly, there was alleged tightness felt, however, a decision was made to continue loading the 6x37 balloon expandable vascular covered stent graft device through the introducer sheath.It was further reported that due to the tightness it was slower to advance the device through the introducer sheath, and that prior to reaching the target lesion a decision was made to remove the device, and use a 5mm stent graft instead.The 6x37 balloon expandable vascular covered stent graft device was then removed from the patient without incident.Reportedly, a 5x37 balloon expandable vascular covered stent graft device was then used and successfully placed in the patient although with alleged difficulty during advancement through the sheath.Furthermore, during the deflation process and advancement of the introducer sheath back over the balloon the sheath allegedly caught on the 5x37 stent graft pushing it distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to again bareback this 6x37 balloon expandable vascular covered stent graft device to place it into the 5x37 stent graft.This 6x37 device was then advanced to the target lesion without any dislodgement however it failed to sit inside the 5x37 stent graft as intended and instead pushed it a little farther into the artery.The 5x37 stent was now covering a branch and thrombus.Therefore, this 6x37 device was not deployed and removed without incident from the patient, and the procedure was completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 stent graft on the left renal.A 12x37 delivery system was also deployed in the sma without further incident.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.Investigation summary: the investigation was confirmed for the reported device incompatibility failure mode.During the functional evaluation of the returned device significant resistance was encountered as the catheter was fed through the 6f sheath.However the device passed through successfully.Based on the available information a definitive root cause has not been determined.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: 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.

• 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: 7649023
• MDR Text Key: 113007364
• Report Number: 9616666-2018-00089
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081482
• UDI-Public: (01)05391522081482
• 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,Followup
• Report Date: 08/09/2018

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: LSM1350637
• Device Lot Number: 50137142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 07/30/2018
• Supplement Dates FDA Received: 07/27/2018; 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1