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

Model Number	LSMU1350726
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
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.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 or Problem Description
It was reported that during treatment of the subclavian artery, the stent graft allegedly could not be inserted through the 6-fr introducer sheath upon accessing the left brachi.A new delivery system was 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, receiving inspection, 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.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.Investigation summary: the investigation is confirmed for the reported device incompatibility issue.The device would not advance through a 6fr sheath during evaluation.However as the stent guard was not returned, the stent may have expanded during transport.Therefore compatibility testing may not be fully representative of the product as received in clearstream.The definitive root cause for the reported device incompatibility 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 to treat the left subclavian vein via left brachial access.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 to treat the left subclavian vein via left brachial access.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 06/2020).
Event or Problem Description
It was reported that during treatment of the subclavian artery, the stent graft allegedly could not be inserted through the 6-fr introducer sheath upon accessing the left brachi.A new delivery system was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANDABLE COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8593495
• Report Number: 9616666-2019-00056
• Device Sequence Number: 2281400
• Product Code: PRL
• UDI-Device Identifier: 05391522081130
• UDI-Public: (01)05391522081130
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: LSMU1350726
• Device Catalogue Number: LSMU1350726
• Device Lot Number: CMBU0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 56