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

Model Number	LSMU1350626
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 investigation is inconclusive for the reported hole in stent issue, as the device was not returned for evaluation.The definitive root cause for the reported hole in stent issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is unknown if there were patient factors, handling or procedural techniques that contributed to the reported issue.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions: prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Do not use if the delivery system cannot be properly flushed.Potential adverse events: covered stent deformation / kink / fracture.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.Placement of two overlapped covered stents: in the event that two covered stents must be placed overlapped, place the distal covered stent first.Ensure approximately 10 mm overlap zone.(expiry date 05/2021).
Event or Problem Description
It was reported that after deployment of a balloon expandable covered stent, a hole was allegedly identified on the stent using angio.Another stent was used to overlap the hole and complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE COVERED STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8109030
• Report Number: 9616666-2018-00173
• Device Sequence Number: 11253158
• Product Code: PRL
• UDI-Device Identifier: 05391522081055
• UDI-Public: (01)05391522081055
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: LSMU1350626
• Device Catalogue Number: LSMU1350626
• Device Lot Number: CMCT0185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1