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

Catalog Number LSM1350637

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Claudication (2550)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

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.Receipt of device is not expected.The investigation is currently in progress.

Event Description

It was reported that there was instent restenosis.The complaint device was implanted (b)(6) 2015 and there were no anomalies or no failure with the device.The stent was implanted in the left common iliac artery.Another stent was also implanted in the right common iliac artery.The procedure was a kissing stent procedure.The patient presented with increasing symptoms of claudication in the left leg.The patient was admitted to hospital (b)(6) 2017 and angiography showed instent restenosis in the left and right common iliac arteries.The restenosis was treated using a 6x80 pta device.Angiography showed a good result.The treatment was successful and the patient was discharged (b)(6) 2017 without sequelae.There was no patient injury reported.

Manufacturer Narrative

It was reported that there was instent restenosis.The complaint device was implanted (b)(6) 2015 and there were no anomalies or no failure with the device.The stent was implanted in the left common iliac artery.Another stent was also implanted in the right common iliac artery.The procedure was a kissing stent procedure.The patient presented with increasing symptoms of claudication in the left leg.The patient was admitted to hospital (b)(6) 2017 and angiography showed instent restenosis in the left and right common iliac arteries.The restenosis was treated using a 6x80 pta device.Angiography showed a good result.The treatment was successful and the patient was discharged (b)(6) 2017 without sequelae.There was no patient injury reported.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the second reported complaint for this lot number and issue to date.The result of the investigation for the first complaint was inconclusive as the sample was not returned for evaluation.The device was not returned for evaluation.The result of the investigation is inconclusive as the sample was not returned for evaluation.Based upon the available information a definitive root cause cannot be determined.It cannot be proven if the complaint stents triggered the restenosis.It is also unknown whether patient factors or procedural techniques contributed to the reported event.Based on analysis performed no additional action is required at this time.The ifu states: 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.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.(b)(4).

Manufacturer Narrative

Manufacturing review: the lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.Investigation summary: the result of the investigation is inconclusive as the sample was not returned for evaluation.Based upon the available information a definitive root cause cannot be determined.It is unknown whether patient factors or procedural techniques contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that there was instent restenosis.The complaint device was implanted (b)(6) 2015 and there were no anomalies or no failure with the device.The stent was implanted in the left common iliac artery.Another stent was also implanted in the right common iliac artery.The procedure was a kissing stent procedure.The patient presented with increasing symptoms of claudication in the left leg.The patient was admitted to hospital (b)(6) 2017 and angiography showed instent restenosis in the left and right common iliac arteries.The restenosis was treated using a 6x80 pta device.Angiography showed a good result.The treatment was successful and the patient was discharged (b)(6) 2017 without sequelae.There was no patient injury reported.New information: it was reported that approximately three years and three months post stent placement, in-stent restenosis of the left common iliac artery was observed during a routine ultrasound examination.Reportedly, no treatment was planned and there was no patient injury.

Event Description

It was reported that there was instent restenosis.The complaint device was implanted (b)(6) 2015 and there were no anomalies or no failure with the device.The stent was implanted in the left common iliac artery.Another stent was also implanted in the right common iliac artery.The procedure was a kissing stent procedure.The patient presented with increasing symptoms of claudication in the left leg.The patient was admitted to hospital (b)(6) 2017 and angiography showed instent restenosis in the left and right common iliac arteries.The restenosis was treated using a 6x80 pta device.Angiography showed a good result.The treatment was successful and the patient was discharged (b)(6) 2017 without sequelae.There was no patient injury reported.It was reported that approximately three years and three months post stent placement, in-stent restenosis of the left common iliac artery was observed during a routine ultrasound examination.Reportedly, no treatment was planned and there was no patient injury.

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent that are cleared in the us.The 510k number and pro code for the lifestream balloon expandable vascular covered stent are identified.  the lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.The result of the investigation is confirmed for the reported instent restenosis issue.The sample was not returned for evaluation.It was assessed that the instent restenosis was ¿definitely related¿ to the study device.The definitive root cause for the reported instent restenosis issue could not be determined based upon available information.It is unknown whether the patient factors contributed to the reported issue.Disease progression, handling or procedural techniques may also have been possible factors to the related event.The ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: adverse events arterial occlusion/restenosis of the treated vessel, restenosis in the treatment area/covered stent edge.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 6817084
• MDR Text Key: 83515915
• Report Number: 9616666-2017-00078
• 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,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: LSM1350637
• Device Lot Number: 50112184
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention