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

Model Number LSMU1350716

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

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: 04/2020).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 treatment of the celiac artery via right femoral artery access, the stent allegedly dislodged from the balloon during deployment and was unintentionally implanted in the splenic artery.There was no reported patient injury.

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.Investigation summary: the investigation is inconclusive for the reported stent dislodgement issue.The stent was not present on the balloon and the balloon had been inflated.The stent was not returned.It is unknown if patient conditions, procedural or handling techniques contributed to the reported event.The event description states that the lifestream was being used for treatment of 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.The definitive root cause for the reported stent dislodgement issue could not be determined based upon available information.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 for treatment of 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.

Event Description

It was reported that during treatment of the celiac artery via right femoral artery access, the stent allegedly dislodged from the balloon during deployment and was unintentionally implanted in the splenic artery.There was no reported patient injury.

• 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 N A ; EI N A
• MDR Report Key: 9404342
• MDR Text Key: 189909929
• Report Number: 9616666-2019-00146
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081543
• UDI-Public: (01)05391522081543
• 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
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LSMU1350716
• Device Catalogue Number: LSMU1350716
• Device Lot Number: CMBS0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR