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

Catalog Number LSM1350938

Device Problems Positioning Failure (1158); Retraction Problem (1536); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.The catalog number identified in 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.(expiry date: 05/2022) 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.

Event Description

It was reported that during stent placement procedure, the delivery system allegedly had difficult in advancing and delivering the stent.It was further reported that stent was removed and replaced with another stent.Reportedly there is an increase in incision site.The patient current status was unknown.

Event Description

It was reported that during a cross-over technique stent placement procedure for the endovascular treatment of an aneurysm in the right iliac artery, the delivery system allegedly had difficult in advancing and the stent dislodged.It was also reported that there was difficulty in retracting the catheter through the introducer sheath.It was further reported that stent was removed and replaced with another stent.Reportedly there is an increase in incision site.The patient current status was unknown.

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.A photograph of two fluoroscopic images is provided.The quality is poor and it is difficult to assess.The fluoroscopic images appear to be centered on the pelvis.One image shows what appears to be a wire/catheter access traveling up and over the bifurcation into the right iliac artery.There also appears to be another wire traveling from the right groin up into the aorta.The next image depicts similar wire access and a partial angiographic run possibly into the right internal iliac artery but this can¿t be confirmed with the imaging provided.There appears to be possibly two stents in the right iliac system, one that travels into the external iliac artery and one into the internal iliac artery.However, this is challenging to definitely assess with the image quality.The result of the investigation is inconclusive for the reported dislodgement, advancement and retraction issues.A definite root cause could not be determined.Labeling review: 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.H10: d4 (expiry date: 05/2022), g4.H11: f10 (device), h6(result, conclusion).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.Device not returned.

Event Description

It was reported that during a cross-over technique stent placement procedure for the endovascular treatment of an aneurysm in the right iliac artery, the delivery system allegedly had difficult in advancing and the stent dislodged.It was also reported that there was difficulty in retracting the catheter through the introducer sheath.It was further reported that stent was removed and replaced with another stent.Reportedly there is an increase in incision site.The patient current status was unknown.

Manufacturer Narrative

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 g4.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.A photograph of two fluoroscopic images is provided.The quality is poor and it is difficult to assess.The fluoroscopic images appear to be centered on the pelvis.One image shows what appears to be a wire/catheter access traveling up and over the bifurcation into the right iliac artery.There also appears to be another wire traveling from the right groin up into the aorta.The next image depicts similar wire access and a partial angiographic run possibly into the right internal iliac artery but this can¿t be confirmed with the imaging provided.There appears to be possibly two stents in the right iliac system, one that travels into the external iliac artery and one into the internal iliac artery.However, this is challenging to definitely assess with the image quality.The result of the investigation is inconclusive for the reported dislodgement, advancement and retraction issues.A definite root cause could not be determined.Labeling review: the instructions 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 for the endovascular treatment of an aneurysm in the right iliac 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.The event description also states that the lifestream was being retracted through the introducer sheath.This is user error."remove the sheath/guiding catheter and endovascular system as a single unit".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.H10: d4 (expiry date: 05/2022), g3 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.

• 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: 10957890
• MDR Text Key: 219854614
• Report Number: 9616666-2020-20028
• Device Sequence Number: 1
• Product Code: PRL
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350938
• Device Lot Number: CMDT0155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/18/2021; 09/08/2021
• Supplement Dates FDA Received: 02/02/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention