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

Catalog Number LSM1350837

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in the report has not been cleared in the us, but is similar to the lifestream balloon expandable covered stent products that are cleared in the us.The pro code and 510 k number for the lifestream balloon expandable covered stent products are identified in common device name and pma #, respectively.No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.Expiry date: 2021-01-31.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 Description

It was reported that prior to inserting the balloon catheter into the introducer sheath, the balloon was allegedly detached from the catheter shaft.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestream balloon expandable covered stent products that are cleared in the us.The pro code and 510 k number for the lifestream balloon expandable covered stent products are identified in d2 and g5, respectively.Manufacturing review: the production history for the device was reviewed and no anomalies were identified.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.This is the first reported complaint for this lot number and issue to date.There have been no other complaints reported of any type for this lot number.Investigation summary: the result of the investigation has unconfirmed the balloon detachment failure mode reported.The evaluation confirmed that the balloon was present on the catheter and entirely intact.The evaluation did observe stent dislocation.The stent was dislocated 7.5mm towards the proximal end of the balloon and was easily moved during evaluation.Based upon the available information a definitive root cause has not been determined.It is unknown whether patient factors, handling or procedural techniques have contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: a device description 1.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 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.Covered stent size selection 3.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 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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation 7.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.8.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.9.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.11.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.12.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 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.Expiry date: 2021-01-31.

Event Description

It was reported that prior to inserting the balloon catheter into the introducer sheath, the balloon was allegedly detached from the catheter shaft.There was no patient contact.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE COVERED STENT
• Type of Device: BALLOON EXPANDABLE COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7720883
• MDR Text Key: 115360330
• Report Number: 9616666-2018-00103
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081642
• UDI-Public: (01)05391522081642
• 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
• Report Date: 09/04/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350837
• Device Lot Number: CMCP0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 80