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

Model Number	LSMU1350816
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.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 or Problem Description
It was reported that during a stent deployment of the right common iliac artery with access gained through the left femoral artery, the stent allegedly caught on the end of the sheath as the sheath was pulled back and dislodged off the balloon.No resistance was felt when advancing the device through the sheath.Both the sheath and stent system were removed as one unit; however, the stent allegedly came off of the sheath in the left femoral artery.A surgical procedure was performed to remove the stent.Another device was used to complete the procedure.The patient was reported as asymptomatic.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the result of the investigation is inconclusive.The sample was not returned for evaluation.User error and procedural techniques may have contributed to the reported issue.The event description states that the "stent allegedly dislodged in the left femoral artery as the delivery system was pulled back through the sheath".This is contrary to what is directed in the instructions for use (ifu).The ifu states "attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in the stent dislodgment".Based upon the available information a definitive root cause cannot be determined.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: apr / 2020; pma/510k; event; concomitant medical products; initial reporter name and address (patient, conclusion).
Event or Problem Description
It was reported that during a deployment of a balloon expandable covered stent in the right common iliac artery with access gained through the left femoral artery, the covered stent allegedly caught on the end of the sheath as the delivery system was pulled back through the sheath and dislodged in the left femoral artery.Reportedly, both the sheath and stent system were removed as one unit; however, a surgical procedure was performed to remove the stent.Another device was used to complete the procedure.The patient was reported as asymptomatic.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7542362
• Report Number: 9616666-2018-00065
• Device Sequence Number: 1433317
• Product Code: PRL
• UDI-Device Identifier: 05391522081628
• UDI-Public: (01)05391522081628
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: LSMU1350816
• Device Catalogue Number: LSMU1350816
• Device Lot Number: CMBS0393
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 93