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

Model Number	LSMU1350616
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.Expiry date: 07/2020.
Event or Problem Description
It was reported that during treatment of the calcific celiac artery via right groin access, the balloon expandable vascular covered stent delivery system allegedly failed to cross the lesion.Therefore, the health care provider (hcp) decided to remove the delivery system through the introducer sheath, causing the stent graft to allegedly partially dislodge from balloon at the hemostatic valve.Reportedly, the stent graft and the delivery system were removed as one unit through the introducer sheath with some difficulty.Another pta balloon catheter and another delivery system were used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted on the dhr, mrb, internal rejects history, manufacturing controls and fmeas.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Based on the severity and lot quantity, the number of events is within the acceptable quality levels.Investigation summary: the investigation is confirmed for the reported stent dislodgement issue reported.The stent was returned on the balloon, but was positioned over the distal markerband.The investigation is inconclusive for the reported failure to advance and retraction issues.There was no tip damage or kinks observed on the device.The sheath had not been returned.The definitive root cause for the reported stent dislodgement and retraction issues could not be determined based upon available information.Patient factors (calcific celiac artery) was the likely contributory factor in the reported issue of failure to advance.The event description states that the lifestream was being used to treat a calcific celiac artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.It is unknown there were other procedural or handling techniques that may have contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: the event description states that the lifestream was being used in the celiac artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.Expiry date: 07/2020.
Event or Problem Description
It was reported that during off-label treatment of the calcific celiac artery via right groin access, the balloon expandable vascular covered stent delivery system allegedly failed to cross the lesion.Therefore, the health care provider (hcp) decided to remove the delivery system through the introducer sheath, causing the stent graft to allegedly partially dislodge from balloon at the hemostatic valve.Reportedly, the stent graft and the delivery system were removed as one unit through the introducer sheath with some difficulty.Another pta balloon catheter and another delivery system were used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 8982405
• Report Number: 9616666-2019-00097
• Device Sequence Number: 16962950
• Product Code: PRL
• UDI-Device Identifier: 05391522081468
• UDI-Public: (01)05391522081468
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 10/08/2019

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: LSMU1350616
• Device Catalogue Number: LSMU1350616
• Device Lot Number: CMBV0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 68