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

Catalog Number LSM1350626

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

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 a stent placement procedure in a visceral branch via left axillary access for endovascular repair of thoraco-abdomial aortic aneurysm, the balloon expandable vascular covered stent allegedly dislodged from the balloon upon deployment attempt.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this was the first complaint reported for this lot number.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 dislodgment / dislocated issue.The stent was returned on the balloon but was dislocated by 3mm towards the distal tip.The definitive root cause for the reported stent dislodgment / dislocated issue could not be determined based upon available information.Per the complaint history review (chr) this is the first complaint reported for this lot number.Based on the severity and lot quantity the number of events is within the acceptable quality level.The event description states that the lifestream was being used in a stent placement procedure in a visceral branch via left axillary access for endovascular repair of thoraco-abdomial aortic aneurysm.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 if patient conditions 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 a stent placement procedure in a visceral branch via left axillary access for endovascular repair of thoraco-abdomial aortic aneurysm.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 04/2020).H11:section a through f - 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 a stent placement procedure in a visceral branch via left axillary access for endovascular repair of thoraco-abdomial aortic aneurysm, the balloon expandable vascular covered stent allegedly dislodged from the balloon upon deployment attempt.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 ; EI
• MDR Report Key: 8646917
• MDR Text Key: 146264784
• Report Number: 9616666-2019-00062
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081475
• UDI-Public: (01)05391522081475
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350626
• Device Lot Number: CMBS0309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR