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

Model Number LSMU0800716

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

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 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
• Type of Device: BALLOON EXPANDABLE 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: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8047007
• MDR Text Key: 127370119
• Report Number: 9616666-2018-00157
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081505
• UDI-Public: (01)05391522081505
• 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: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LSMU0800716
• Device Catalogue Number: LSMU0800716
• Device Lot Number: CMBV0441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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 Age: 71 YR
• Patient Weight: 57