MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT

Model Number VIUS09060

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the device end allegedly curled up.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records was 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.(expiration date: 12/2023).

Event Description

It was reported that during a stent placement procedure, the device end allegedly curled up.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: it was not known in which clinical indication the product was used.Potential issues were found addressed.The instructions for use states: 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' a stent sizing table is part of the instructions for use describing the relationship between unconstrained stent diameter and the vessel diameter.Regarding a damaged device prior to use the instructions for use states: 'visually inspect the bard® lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.' based on the instructions for use, pre and post dilation are left to the discretion of the physician.Holding and handling of the system during deployment including unpacking and preparation were found described.H10: d4 (expiry date: 12/2023), g3 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: LIFESTAR VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13480639
• MDR Text Key: 285674294
• Report Number: 9681442-2022-00024
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519005485
• UDI-Public: (01)04049519005485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIUS09060
• Device Catalogue Number: VIUS09060
• Device Lot Number: ANEZ3065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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