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

Model Number	LSMU0800716
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: jul / 2020.
Event or Problem Description
It was reported that during positioning of the balloon expandable covered stent in the celiac artery, the health care provider (hcp) did not want to deploy the covered stent through the tight stenosis of the lesion without the protection of the sheath; therefore, the hcp retracted the partially exposed covered stent back into the introducer sheath and pulled the balloon catheter back to the hemostatic valve of the sheath.At this point, the balloon catheter was completely removed and the hcp allegedly identified that the covered stent was no longer attached to the balloon catheter.Fluoroscopy was used to locate the covered stent at the valve of the introducer sheath.It was further reported that the sheath was removed and replaced with another.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE COVERED STENT
• Common Device Name: BALLOON EXPANDABLE COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8047007
• Report Number: 9616666-2018-00157
• Device Sequence Number: 11122304
• Product Code: PRL
• UDI-Device Identifier: 05391522081505
• UDI-Public: (01)05391522081505
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSMU0800716
• Device Catalogue Number: LSMU0800716
• Device Lot Number: CMBV0441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 57