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

Model Number LSMU1350938

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)

Event Date 11/09/2017

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.Receipt of device is not expected.The investigation is currently in progress.

Event Description

It was reported that the stent dislodged and migrated requiring a surgical cut down to remove it.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 patient was to be treated for subclavian stenosis.The complaint device was to be used in the left ostial subclavian lesion.The lesion was 40% calcified and there was stenosis.The lesion was tortuous.Femoral access was made.A 7fr shuttle, 90cm introducer sheath was used.The complaint device was prepped correctly and delivered over a 035 guidewire through the sheath to the target lesion.The tracking path was 40% calcified.The stent graft was protected by the sheath during all steps of tracking to the target lesion.There was no resistance felt when tracking the device.The 9x38 stent was decided to be too long to treat the lesion and it was therefore decided to be removed.The device was removed over the wire back through the sheath.When retracting the device the stent dislodged from the balloon near the edge of the sheath.There was a bend in the wire also which was thought may have contributed to the dislodgement.The stent was sitting in a less than optimal location and so was pushed forward and ended up migrating down the ulnar artery.A bare metal balloon expandable stent was placed in place of the complaint device with a good result.Vascular surgery was consulted and ultimately the patient was brought to the operating room for a small cut down on the extremity and the lifestream was surgically removed/ retrieved from the ulnar artery fully intact.The patient is doing well and has been discharged.Air evacuation was performed prior to inserting the device.Pre-dilatation was not performed.The doctor was aware that the device should not be pulled back into the sheath and that the indication for use is the common and external iliac artery.

Manufacturer Narrative

It was reported that the stent dislodged and migrated requiring a surgical cut down to remove it.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 patient was to be treated for subclavian stenosis.The complaint device was to be used in the left ostial subclavian lesion.The lesion was 40% calcified and there was stenosis.The lesion was tortuous.Femoral access was made.A 7fr shuttle, 90cm introducer sheath was used.The complaint device was prepped correctly and delivered over a 035 guidewire through the sheath to the target lesion.The tracking path was 40% calcified.The stent graft was protected by the sheath during all steps of tracking to the target lesion.There was no resistance felt when tracking the device.The 9x38 stent was decided to be too long to treat the lesion and it was therefore decided to be removed.The device was removed over the wire back through the sheath.When retracting the device the stent dislodged from the balloon near the edge of the sheath.There was a bend in the wire also which was thought may have contributed to the dislodgement.The stent was sitting in a less than optimal location and so was pushed forward and ended up migrating down the ulnar artery.A bare metal balloon expandable stent was placed in place of the complaint device with a good result.Vascular surgery was consulted and ultimately the patient was brought to the or for a small cut down on the extremity and the lifestream was surgically removed/ retrieved from the ulnar artery fully intact.The patient is doing well and has been discharged.Air evacuation was performed prior to inserting the device.Pre-dilatation was not performed.The doctor was aware that the device should not be pulled back into the sheath and that the indication for use is the common and external iliac artery.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.User error and the use of the device off label may have contributed to the reported issue.The event description states that the device was removed back through the sheath during the procedure.When retracting the device the stent dislodged from the balloon near the edge of the sheath.There was a bend in the wire also which was thought may have contributed to the dislodgement.This is contrary to what is directed in the ifu.The ifu states "attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in the stent dislodgment".The event information also described that the lesion being treated with the lifestream device was the left ostial subclavian lesion.This indicates that the device was been 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 lesion was reportedly 40% calcified, was tortuous and there was stenosis.The doctor was also aware that the device should not be pulled back into the sheath and that the indication for use is the common and external iliac artery.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 occurrence rate for this failure mode is 0.07% (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 oct 17 is 0.02%.While this figure is slightly higher than the predicted rate of 0.01% this calculation is based on 14 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: 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).

Event Description

It was reported that the stent dislodged and migrated requiring a surgical cut down to remove it.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 patient was to be treated for subclavian stenosis.The complaint device was to be used in the left ostial subclavian lesion.The lesion was 40% calcified and there was stenosis.The lesion was tortuous.Femoral access was made.A 7fr shuttle, 90cm introducer sheath was used.The complaint device was prepped correctly and delivered over a 035 guidewire through the sheath to the target lesion.The tracking path was 40% calcified.The stent graft was protected by the sheath during all steps of tracking to the target lesion.There was no resistance felt when tracking the device.The 9x38 stent was decided to be too long to treat the lesion and it was therefore decided to be removed.The device was removed over the wire back through the sheath.When retracting the device the stent dislodged from the balloon near the edge of the sheath.There was a bend in the wire also which was thought may have contributed to the dislodgement.The stent was sitting in a less than optimal location and so was pushed forward and ended up migrating down the ulnar artery.A bare metal balloon expandable stent was placed in place of the complaint device with a good result.Vascular surgery was consulted and ultimately the patient was brought to the or for a small cut down on the extremity and the lifestream was surgically removed/ retrieved from the ulnar artery fully intact.The patient is doing well and has been discharged.Air evacuation was performed prior to inserting the device.Pre-dilatation was not performed.The doctor was aware that the device should not be pulled back into the sheath and that the indication for use is the common and external iliac artery.

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 inconclusive for the stent dislodged failure mode.The stent was not returned with the device.From the evaluation it appeared that the balloon had been inflated.User error and the use of the device off label may have contributed to the reported issue.The event description states that the device was removed back through the sheath during the procedure.When retracting the device the stent dislodged from the balloon near the edge of the sheath.There was a bend in the wire also which was thought may have contributed to the dislodgement.This is contrary to what is directed in the ifu.It states "attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in the stent dislodgment".The event information also described that the lesion been treated for the lifestream device was the left ostial subclavian lesion.This indicates that the device was been 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 lesion was reportedly 40% calcified, was tortuous and there was stenosis.The doctor was also aware that the device should not be pulled back into the sheath and that the indication for use is the common and external iliac artery.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: 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.Outcomes attributed to adverse event, relevant tests/laboratory data, other relevant history, brand name, common device name, mfr site, device evaluated by mfr (eval code & desc- method 1, method 2, conclusion 1).

• 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: 7085972
• MDR Text Key: 93808337
• Report Number: 9616666-2017-00141
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081260
• UDI-Public: (01)05391522081260
• 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,Followup
• Report Date: 09/27/2018

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: LSMU1350938
• Device Catalogue Number: LSMU1350938
• Device Lot Number: CMBP0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR