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

Model Number	LSMU1350726
Medical Device Problem Codes	Retraction Problem (1536); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the stent allegedly dislodged from the catheter while removal of the catheter.It was further reported that the stent was advanced further down the artery and deployed where it was not needed.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records 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 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.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned to the manufacturer for evaluation.Therefore, the result of the investigation is inconclusive for the reported stent dislodgement issue and catheter retraction issues.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: indication for use: the lifestream balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Contraindications :¿ patients who are judged to have lesions that prevent complete expansion of the implant based on the lesion morphology, the diagnostic angiography and/or lesion response during pre-dilation.Warnings ¿ do not use if packaging/pouch is damaged.¿ should excessive resistance be felt at any time during the insertion process, do not force passage.¿ attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement ¿ the covered stent cannot be repositioned after it is deployed.¿ do not expose the covered stent to temperatures higher than 500 °f (260 °c).Eptfe decomposes at elevated temperatures, producing highly toxic decomposition products.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.¿ anatomical variances may complicate the procedure; use caution when advancing the endovascular system through tortuous or difficult anatomy.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.¿ store in a cool and dry place.Keep away from sunlight.Directions for use: site access and preparation 1.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.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Endovascular system preparation: 4.Carefully remove the selected device from the package.5.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.Introduction of the endovascular system and placement of the covered stent 13.Advance the endovascular system over the guidewire into the introducer sheath.14.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.15.Slowly inflate the endovascular system balloon to nominal pressure, expanding the covered stent.Confirm complete expansion via fluoroscopic visualization.A 15 ¿ 30 second inflation time is recommended.Important: do not exceed the rated burst pressure of the delivery system.16.After covered stent deployment, apply negative pressure to the balloon until it is fully deflated.Withdraw the delivery system while maintaining negative pressure with the guidewire remaining across the lesion.17.Confirm optimal covered stent wall apposition using standard angiographic techniques.If the covered stent has not achieved full wall apposition, a post dilation with an appropriately sized balloon should be performed.5-8 mm devices may be post-dilated with balloons up to 10 mm in diameter.9-12 mm devices may be post-dilated with balloons up to 12 mm in diameter.H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the stent allegedly dislodged from the catheter while removal of the catheter.There was difficulty retracting the device and it was further reported that the stent was advanced further down the artery and deployed where it was not needed.There was no reported patient injury.

• Brand Name: LIFESTREAM
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 12381213
• Report Number: 9616666-2021-00134
• Device Sequence Number: 11073961
• Product Code: PRL
• UDI-Device Identifier: 05391522081130
• UDI-Public: (01)05391522081130
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/06/2021

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: CMCY0405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 08/28/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1