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

Model Number	LSMU0800637
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
Event or Problem Description
It was reported that during treatment of the iliac via groin access, the delivery system allegedly could not be inserted through the introducer sheath after a few attempts.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment of the iliac via groin access, the delivery system allegedly could not be inserted through two different introducer sheaths after a few attempts.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not performed as the lot number was not provided.Investigation summary: the investigation is unconfirmed for the reported device incompatibility issue.Although there was difficulty encountered, the device successfully passed through an own 6fr terumo radifocus sheath during the evaluation.The complainant sheaths and stent sleeve were not returned.A 0.035" guidewire was also successfully inserted through the device during evaluation, though there was some resistance as it passed through the kink on the inner close to the proximal marker band.The presence of dried blood on the guidewire after it exited the distal tip likley also contributed to the resistance.The root cause could not be determined based upon the available information received from the field communications and the sample evaluation.It is unknown if there were procedural or handling techniques that contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: precautions ¿ the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: ¿ covered stent dislodgement from balloon during tracking procedure ¿ covered stent misplacement during placement procedure directions for use: site access and preparation ¿ using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.Covered stent size selection ¿ select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation ¿ carefully remove the selected device from the package.¿ inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.¿ flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system air evacuation ¿ a 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.¿ with the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.¿ induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.10.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.¿ attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.¿ verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent ¿ advance the endovascular system over the guidewire into the introducer sheath.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANABLE VASCLUAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9572355
• Report Number: 9616666-2019-00155
• Device Sequence Number: 19680321
• Product Code: PRL
• UDI-Device Identifier: 05391522081024
• UDI-Public: (01)05391522081024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: LSMU0800637
• Device Catalogue Number: LSMU0800637
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 60