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

Catalog Number LSMU1350758

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2017

Event Type  malfunction  

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.It is unknown if the device will be returned.The investigation is currently in progress.Not returned.

Event Description

It was reported that the stent partially dislodged.The stent partially dislodged from the balloon prior to deployment during an attempt to treat a heavy calcified lesion in the common iliac.It was reported that the treatment was done up and over with a 7fr sheath.Reportedly, the health care provider was able to successfully deploy the stent.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent partially dislodged.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 target lesion was the left external iliac artery.The lesion was severely calcified and was not tortuous.The patient was being treated for stenosis.A contralateral approach was made.Access was made via the right common femoral artery.A n advantage.035¿ 260cm guidewire and a terumo destination 7f 45cm introducer sheath were used.The stent got caught on some calcium and partially dislodged when outside of the sheath just prior to deployment near the target lesion.To deploy the stent successfully the operator deployed the portion of the stent still on the balloon and then pulled the balloon back to deploy the rest of it.The stent was deployed at the target lesion but was reportedly slightly off.Air evacuation was not performed.Multiple attempts to insert the device into the sheath were not required.There was no resistance felt when tracking the device.The stent graft was not protected during all steps of tracking to the target lesion.The stent was never pulled back through the sheath.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 returned for evaluation.However user error may have contributed to the reported issue.The event description states that air evacuation was not performed.It also describes that the stent graft was not protected during all steps of tracking to the target lesion.This is contrary to the directions for use of the the ifu.It is also possible that patient factors (lesion was severely calcified) may have contributed to the reported issue.Based upon the available information a definitive root cause has not been determined.Based on analysis performed no additional action is required at this time.(b)(4).The ifu states: 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 partially dislodged.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 target lesion was the left external iliac artery.The lesion was severely calcified and was not tortuous.The patient was being treated for stenosis.A contralateral approach was made.Access was made via the right common femoral artery.An advantage.035¿ 260cm guidewire and a terumo destination 7f 45cm introducer sheath were used.The stent got caught on some calcium and partially dislodged when outside of the sheath just prior to deployment near the target lesion.To deploy the stent successfully the operator deployed the portion of the stent still on the balloon and then pulled the balloon back to deploy the rest of it.The stent was deployed at the target lesion but was reportedly slightly off.Air evacuation was not performed.Multiple attempts to insert the device into the sheath were not required.There was no resistance felt when tracking the device.The stent graft was not protected during all steps of tracking to the target lesion.The stent was never pulled back through the sheath.There was no reported patient injury.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABE 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: 6816950
• MDR Text Key: 83747862
• Report Number: 9616666-2017-00076
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

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 Expiration Date: 02/29/2020
• Device Catalogue Number: LSMU1350758
• Device Lot Number: CMBQ0391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1