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

Catalog Number UNKNOWN LIFESTREAM OUS

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified in section 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.The information provided by bd 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 bd.

Event Description

It was reported that during evaluation of the returned device a break was allegedly identified.No further information was provided.

Event Description

It was reported that during evaluation of the returned device a break was allegedly identified.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review was not performed as a lot number was not provided.Investigation summary: the investigation is confirmed for the reported stent torn issue.There were tears/splits noted in 3 of the 4 returned stents.One of the stents was not a lifestream stent the definitive root cause for the reported stent torn issue could not be determined based upon available information.A manufacturing review could not be performed as the lot number was not provided.Due to the unusual nature of the event, lengthy efforts were made to obtain information regarding the procedural and handling techniques used but were unsuccessful.However if any of these particulars are made available the file will be reopened and updated accordingly.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 and 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.(device code: removed 1069 - break).

• 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: 8652141
• MDR Text Key: 146482629
• Report Number: 9616666-2019-00065
• Device Sequence Number: 1
• Product Code: PRL
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN LIFESTREAM OUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1