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

Catalog Number UNKNOWN LIFESTREAM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device not returned.

Event Description

It was reported that after a stent placement procedure, the patient allegedly suffered by allergy like rash.The current patient status was unknown.

Event Description

It was reported that after a stent placement procedure, the patient allegedly suffered an allergy like rash.The current patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the device was not returned for evaluation.The result of the investigation is confirmed for the reported implant allergic reaction.User error is the likely contributor to the reported event.It was stated in the communications that the patient advised the physician that they had a stainless steel allergy post the implant placement procedure.The definitive root cause for the reported implant allergic reaction could not be determined based upon the available information.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: contraindications the lifestream balloon expandable vascular covered stent is contraindicated for use in: patients with uncorrected bleeding disorders patients who cannot receive recommended antiplatelet and/or anticoagulation therapy patients who are judged to have lesions that prevent complete expansion of the implant based on the lesion morphology, the diagnostic angiography and/or lesion response during pre-dilation.Lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system lesion locations subject to external compression warnings patients with allergies or hypersensitivity to stainless steel, nickel, chromium or eptfe may suffer an allergic response to this implant.Potential adverse events drug reaction or allergic reaction to medication, substances or materials used for the procedure (e.G.Anticoagulation or antiplatelet agent, contrast medium, stent or catheter materials) h11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 12426171
• MDR Text Key: 270497240
• Report Number: 9616666-2021-00140
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN LIFESTREAM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/04/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other