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

Model Number	LSMU1351058
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical images were provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(expiry date 082021).
Event or Problem Description
It was reported that approximately four months post a balloon expandable covered stent placement procedure in the right iliac artery of the aorta via access through the left common femoral artery, the patient presented with pain in the leg.It was further reported that the stent was allegedly found to be shorter than labeled.Reportedly, the covered stent remains implanted and an additional procedure is intended to be performed to place an additional covered stent in an attempt to resolve the pain and cover the treatment site.The patient is reportedly stable.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided, and the lot history records have been reviewed.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the investigation is inconclusive for the reported stent length issue.The sample was not returned for evaluation.Medical images were provided but were inconclusive.The complainant reported approximately 4 months post a balloon expandable covered stent placement procedure in the right iliac artery post surgery that the stent was shorter than labelled.No further information was provided i.E.The length of the stent nor the length stated on the product hub or packaging.The definitive root cause for the reported stent length issue could not be determined based upon information received from the field communications or images of stent placements provided it is unknown if patient factors, procedural or handling techniques contributed to the reported event.Labeling review: warnings: ¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Potential adverse events: ¿ pain 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.H10: d4 (expiry date 082021).
Event or Problem Description
It was reported that approximately four months post a balloon expandable covered stent placement procedure in the right iliac artery of the aorta via access through the left common femoral artery, the patient presented with pain in the leg.It was further reported that the stent was allegedly found to be shorter than labeled.Reportedly, the covered stent remains implanted and an additional procedure is intended to be performed to place an additional covered stent in an attempt to resolve the pain and cover the treatment site.The patient is reportedly stable.

• 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 N A ; EI N A
• MDR Report Key: 9723442
• Report Number: 9616666-2020-00017
• Device Sequence Number: 14041734
• Product Code: PRL
• UDI-Device Identifier: 05391522081314
• UDI-Public: (01)05391522081314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/27/2020

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 Model Number: LSMU1351058
• Device Catalogue Number: LSMU1351058
• Device Lot Number: CMCW0408
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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: 64 YR