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

Catalog Number LSM1350737

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2020

Event Type  malfunction  

Manufacturer Narrative

A photo and video were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.The catalog number identified in section has not been cleared in the u.S.But, it is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.(expiry date: 04/2021).

Event Description

It was reported that prior to use, the stent graft allegedly dislodged as the guard protector was being removed, rendering the device unusable.It was further reported that three additional devices were used to complete the procedure.There was no reported patient contact.

Event Description

It was reported that after removal of the stent guard during preparation, the stent graft allegedly dislodged as the guard protector was being removed, rendering the device unusable.It was further reported that three additional devices were used to complete the procedure.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is confirmed for the reported dislodgement issue.The evaluation of the device observed that the stent was dislocated on the balloon by 1.5mm towards the distal tip.It was positioned over the distal markerband and was easily removed from the device during evaluation.Two images provided for review corresponded for the reported device.A video mp4 file was also provided demonstrated the reported dislodgement issue reported.The root cause for the dislodgement issue could not be determined based upon the available information received from the field communications, the returned sample or the images and mp4 video file provided.It is unknown if there were procedural or handling techniques that 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: precautions ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: ¿ covered stent dislodgement from balloon during tracking procedure ¿ covered stent misplacement during placement procedure 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.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.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.¿ 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.H10: d4(expiry date: 02/2022).

• 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 N A ; EI N A
• MDR Report Key: 9918491
• MDR Text Key: 195102427
• Report Number: 9616666-2020-00024
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081567
• UDI-Public: (01)05391522081567
• 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
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350737
• Device Lot Number: CMDQ0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1