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

Catalog Number LSM1351238

Device Problems Deflation Problem (1149); Retraction Problem (1536); Stretched (1601)

Patient Problem Injury (2348)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending, however photos have been provided.The investigation of the reported event is currently underway.Expiry date (01/2023).

Event Description

It was reported that during stent placement in superior mesenteric artery, the balloon allegedly remained inflated and blocked in the introducer.It was further reported that the balloon, introducer and guidewire were removed as a single unit.Reportedly, another covered stent was used to complete the procedure.The patient was reported as stable.

Event Description

It was reported that during stent placement in superior mesenteric artery, the balloon allegedly remained inflated and blocked in the introducer.It was further reported that the balloon, introducer and guidewire were removed as a single unit causing delayed intervention and prolongation of anesthesia.Reportedly, another covered stent was used to complete the procedure.The patient was reported as stable.

Manufacturer Narrative

H10: manufacturing review: a complaint lot history review was carried out for lot number.This is the first reported complaint reported for this product/lot number combination.Based on the severity and lot quantity the number of events is below the acceptable quality level.Investigation summary: the sample was not returned for evaluation.The two images provided were of a lifestream device within a sheath, the distal tip and the cone of the balloon is seen protruding out from the distal end of the sheath.There appears to be some clear liquid within the cone.User issues may have contributed to the reported retraction issues if the balloon was not fully deflated under vacuum.The investigation is inconclusive for the reported deflation and retraction issues.The definitive root cause for the reported deflation and retraction issues could not be determined based upon information received from the field communications and images provided.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used in the superior mesenteric 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.H10: d4 expiry date (01/2023), g4.H11: b5, d10, h6(result, conclusion).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 stent placement in superior mesenteric artery, the balloon allegedly remained inflated and blocked in the introducer.It was further reported that the balloon, introducer and guidewire were removed as a single unit causing delayed intervention and prolongation of anesthesia.Reportedly, another covered stent was used to complete the procedure.The patient was reported as stable.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: two photos were provided and reviewed.The first image consists of what appears to be a lifestream device with hub markings 12 x 38mm 135cm.The majority of the lifestream device is within a sheath of unknown size and manufacturer.The side tube of the sheath is filled with a dark substance.The distal tip and the balloon cone section is protruding the distal tip of the sheath.There appears to be some clear substance within the balloon cone but this cannot be fully confirmed.The second image consists of what appears to be the same lifestream device and introducer sheath.This image provides a closer view of lifestream distal tip and the balloon cone section protruding the distal tip of the sheath.Again there is evidence of a clear substance within the balloon distal cone though it is only partially filled.The sample was returned to the manufacturer for evaluation.When the device was removed from the sheath, the balloon was inflated to 2atm with air.It deflated successfully.The investigation is unconfirmed for the reported deflation issue.The sample was returned lodged within the sheath.The distal tip and the balloon cone section of 15mm in length was outside the sheath distal tip, the latter of which was also damaged.The device could not be removed from the sheath.There was an area of stretching noted on the outer measuring 25mm in length.This is unlikely to be manufacturing related as a 100% visual inspection for catheter defects is performed during catheter production.The lifestream was eventually removed from the sheath by cutting the device at the hub , it was then removed from the sheath from the distal side.The device was bloody when removed.The sheath was inspected for the stent but none was present.The investigation is confirmed for the reported retraction issue.The definitive root cause could not be determined based upon available information received from the field communication, images provided and device evaluation.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used in the superior mesenteric 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.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g5.H10: d4 (expiry date 01/2023),g4,h6(method: 3331).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.

• Brand Name: LIFESTREAM
• 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: 10132664
• MDR Text Key: 194464661
• Report Number: 9616666-2020-00037
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081765
• UDI-Public: (01)05391522081765
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1351238
• Device Lot Number: CMEP0371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other