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

Catalog Number LSM0800637

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 03/21/2019

Event Type  Death  

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.The catalog number identified in section has not been cleared in the u.S.But, it is similar to the lifestream balloon expandable covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable covered stent products are identified.

Event Description

It was reported that during a fenestrated graft procedure, a wire was inserted into the renal artery with a competitor's introducer sheath.Allegedly the sheath was unable to reach the renal artery; the stent graft was inserted through the introducer sheath and was advanced to the right renal artery.Reportedly, the health care provider made an attempt to retract the stent graft into the sheath; however, when this attempt was made, the stent allegedly dislodged.It was further reported another wire and device with a balloon was inserted to attempt to capture the stent and was implanted.It was reported that the patient lost the right kidney.Furthermore, the patient expired post-procedure.

Event Description

It was reported that during a fenestrated graft procedure, a wire was inserted into the renal artery with a competitor's introducer sheath.Allegedly the sheath was unable to reach the renal artery; the stent graft was inserted through the introducer sheath and was advanced to the right renal artery.Reportedly, the health care provider made an attempt to retract the stent graft into the sheath; however, when this attempt was made, the stent allegedly dislodged.It was further reported another wire and device with a balloon was inserted to attempt to capture the stent and was implanted.It was reported that the patient lost the right kidney.Furthermore, the patient expired post-procedure.

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 dislodgment and retraction issues.The device was not returned for evaluation.The event description states that the lifestream was being used in a fenestrated graft procedure.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 factors or handling techniques were factors in the reported issue.The root cause for the reported stent dislodgement issue could not be determined based upon the available information received from the field communications and manufacturing documentation.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 fenestrated graft procedure.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 catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the lifestream balloon expandable covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable covered stent products are identified in d2 and g5.

• 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: 8525385
• MDR Text Key: 142319947
• Report Number: 9616666-2019-00038
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081444
• UDI-Public: (01)05391522081444
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0800637
• Device Lot Number: CMCV0169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 85