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

Catalog Number LSMU1350737

Device Problems Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Foreign Body In Patient (2687)

Event Date 10/12/2017

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 in the patient.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 being treated for high grade stenosis.The target lesion was the left subclavian artery.The lesion was highly calcified and the rate of stenosis was 90%.The lesion as not tortuous.A rosen 260 guidewire and a 7f terumo introducer sheath were used.Pre dilatation was performed with a mm balloon and was inflated to at least 6atm.Access was made through the left brachial artery.There were two stents, the complaint device and another lifestream device.The devices were inserted into the patient.The devices were advanced and there was resistance felt when they crossed the lesion.Reportedly both stents dislodged in the patient body when crossing through the lesion.The balloons were pulled back to the stent and then deployed at the distal brachial artery.One of the stents deployed inside the other stent.The stents were not protected by the sheath during all steps of tracking to the lesion.Air evacuation was not performed.Multiple attempts to insert the device were not required.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent dislodged in the patient.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 being treated for high grade stenosis.The target lesion was the left subclavian artery.The lesion was highly calcified and the rate of stenosis was 90%.The lesion was not tortuous.A rosen 260 guidewire and a 7f terumo introducer sheath were used.Pre dilatation was performed with a mm balloon and was inflated to at least 6atm.Access was made through the left brachial artery.There were two stents, the complaint device and another lifestream device.The devices were inserted into the patient.The devices were advanced and there was resistance felt when they crossed the lesion.Reportedly both stents dislodged in the patient body when crossing through the lesion.The balloons were pulled back to the stent and then deployed at the distal brachial artery.One of the stents deployed inside the other stent.The stents were not protected by the sheath during all steps of tracking to the lesion.Air evacuation was not performed.Multiple attempts to insert the device were not required.Another device was used to complete the procedure.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 second reported complaint for this lot number and issue to date.The first complaint was inconclusive as the device was not returned.For this complaint the device was not returned for evaluation.The result of the investigation is inconclusive.The sample was not returned for evaluation.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 not protected by the sheath during all steps of tracking to the lesion.Air evacuation was also not performed.This is contrary to what is directed in the ifu.The event information also described that the lesion been treated for the lifestream device was the subclavian artery.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 highly calcified and the rate of stenosis was 90%.Based upon the available information a definitive root cause cannot be determined.Based on analysis performed no additional action is required at this time.(b)(4).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).

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE 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: 7028475
• MDR Text Key: 91939894
• Report Number: 9616666-2017-00127
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: LSMU1350737
• Device Lot Number: CMBS0365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 79