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

Model Number	LSMU0800726
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records has been reviewed.The device was returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during preparation, the balloon expandable vascular covered stent catheter was allegedly unable to pass through the 6fr introducer sheath.Another balloon expandable vascular covered stent catheter was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
H10: 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 result of the investigation is unconfirmed for the reported failure mode of the inability to load the device through a 6fr sheath.Although there was some resistance encountered as the catheter was being fed through the sheath, the device was inserted successfully.Based upon the available information a definitive root cause has not been determined.It is unknown if there were procedural or handling techniques that contributed to the reported event.Labeling review: a device description.Implant the lifestream¿ balloon expandable vascular covered stent is comprised of an electropolished balloon-expandable stent made from 316l stainless steel, encapsulated between two layers of eptfe.B indication for use the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.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.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.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.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.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath / guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.
Event or Problem Description
It was reported that during preparation, the balloon expandable vascular covered stent catheter was allegedly unable to pass through the 6fr introducer sheath.Another balloon expandable vascular covered stent catheter was used to complete the procedure.There was no patient contact.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7640039
• Report Number: 9616666-2018-00086
• Device Sequence Number: 2244728
• Product Code: PRL
• UDI-Device Identifier: 05391522081093
• UDI-Public: (01)05391522081093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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: LSMU0800726
• Device Catalogue Number: LSMU0800726
• Device Lot Number: CMBQ0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 59