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

Catalog Number LSMU1350758

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

Receipt of device is expected.The investigation is currently in progress.

Event Description

It was reported that the stent came off the balloon catheter prior to getting into the sheath.There was no patient injury reported.

Manufacturer Narrative

It was reported that the stent came off the balloon catheter when the stent guard was removed.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and there was no difficulty removing the stent cover.However, when the stent guard was removed the stent dislodged.The target lesion was the external iliac artery.Access was made via the left femoral artery.The patient was being treated for stenosis.A 035 terumo glidewire guidewire and a 7f terumo destination introducer sheath were used.The stent reportedly dislodged outside the patient, when the stent guard was removed, prior to being inserted into the sheath.Multiple attempts to insert the device into the sheath were not made.Air evacuation was performed prior to attempting to insert the device into the sheath.Another product was used to complete the procedure.Guidewire access was maintained throughout the procedure.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 first reported complaint for this lot number and issue to date.The device was returned for evaluation.External and internal packaging was returned.The hub was printed as expected and there were no visual defects noted.The device arrived back without the stent guard.No visual defects were noted on the tip, inner or outer.The stent was returned on the device but it was positioned approx.1mm towards the proximal side of the balloon.The stent was easily moved over the balloon.No damage was observed on the balloon.There was no evidence that the balloon had been inflated.No functional examination was carried out on the device as it was not applicable to the complaint.The result of the investigation is confirmed.The evaluation of the returned device has confirmed the stent dislodged/dislocated failure mode reported.The stent was positioned approx.1mm towards the proximal side of the balloon.Based upon the available information a definitive root cause cannot be determined.It is also unknown whether handling o procedural techniques contributed to the reported event.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated occurrence rate for this failure mode is (b)(4) (last 24 months) and is hence higher than the predicted rate of (b)(4) the rate is decreasing since the process improvement (action from capa) was introduced into production during sept 16.The current rate from sept 16 to sept 17 is (b)(4).While this figure is slightly higher than the predicted rate of (b)(4) this calculation is based on 13 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is (b)(4) which is equal to the predicted rate.The ifu states: 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).

Event Description

It was reported that the stent came off the balloon catheter when the stent guard was removed.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and there was no difficulty removing the stent cover.However, when the stent guard was removed the stent dislodged.The target lesion was the external iliac artery.Access was made via the left femoral artery.The patient was being treated for stenosis.A 035 terumo glidewire guidewire and a 7f terumo destination introducer sheath were used.The stent reportedly dislodged outside the patient, when the stent guard was removed, prior to being inserted into the sheath.Multiple attempts to insert the device into the sheath were not made.Air evacuation was performed prior to attempting to insert the device into the sheath.Another product was used to complete the procedure.Guidewire access was maintained throughout the procedure.There was no patient injury reported.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 6954811
• MDR Text Key: 90651214
• Report Number: 9616666-2017-00110
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: LSMU1350758
• Device Lot Number: CMBT0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 82