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

Catalog Number LSM1350537

Device Problems Retraction Problem (1536); Delivery System Failure (2905); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified in this report has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified in this report.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 during an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma) procedure; the device was passed through a cook hemostatic valve before going through a 6fr cook introducer sheath via the right groin into the aorta; loading the device over an 0.035" guidewire and into the sheath.Reportedly, the 5x37 balloon expandable vascular covered stent device was 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 stent pushing the stent graft distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to bareback a 6x37 balloon expandable vascular covered stent device to deploy the stent graft into the 5x37 stent graft.The 6x37 device was 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 graft was now covering a branch and thrombus.Therefore, the 6x37 device was not deployed and was removed without incident from the patient, and the procedure was then completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 device 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

H10: manufacturing review: a manufacturing review could not be performed as the lot number was unknown.Investigation summary: the investigation is inconclusive for the reported advancement issue as the device was not returned for evaluation.The sheath used is in accordance with ifu labeling.It should be noted that the device was used off label.The event description outlines that the stent was used in an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma) procedure.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.Handling and associated procedural techniques performed because of the off label use may have contributed to the reported issue.The definitive root cause for the reported advancement issue could not be determined based upon available information.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.

Event Description

It was reported that during an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma) procedure; the device was passed through a cook hemostatic valve before going through a 6fr cook introducer sheath via the right groin into the aorta; loading the device over an 0.035" guidewire and into the sheath.Reportedly, the 5x37 balloon expandable vascular covered stent device was 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 stent pushing the stent graft distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to bareback a 6x37 balloon expandable vascular covered stent device to deploy the stent graft into the 5x37 stent graft.The 6x37 device was 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 graft was now covering a branch and thrombus.Therefore, the 6x37 device was not deployed and was removed without incident from the patient, and the procedure was then completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 device 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: a manufacturing review could not be performed as the lot number was unknown.Investigation summary: the investigation was inconclusive since the sample was not returned for evaluation.The sheath used was in accordance with ifu labeling.Based on the available information a definitive root cause has not been determined.It is unknown whether handling or procedural techniques may have 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: 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.

Event Description

It was reported that during an endovascular fenestrated aortic graft in the renals and the superior mesenteric artery (sma) procedure; the device was passed through a cook hemostatic valve before going through a 6fr cook introducer sheath via the right groin into the aorta; loading the device over an 0.035" guidewire and into the sheath.Reportedly, the 5x37 balloon expandable vascular covered stent device was 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 stent pushing the stent graft distally into the right renal artery.The stent was no longer making a seal, therefore, a decision was made to bareback a 6x37 balloon expandable vascular covered stent device to deploy the stent graft into the 5x37 stent graft.The 6x37 device was 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 graft was now covering a branch and thrombus.Therefore, the 6x37 device was not deployed and was removed without incident from the patient, and the procedure was then completed using a 6x27 balloon expandable vascular covered stent device which was delivered bareback to the right renal creating the seal before the 5x37 device on the left renal.A 12x37 delivery system was also deployed in the sma without further incident.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: 7648955
• MDR Text Key: 113010548
• Report Number: 9616666-2018-00088
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081413
• UDI-Public: (01)05391522081413
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350537
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1