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

Catalog Number	EX061503CS
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent placement procedure in the left proximal superficial femoral artery, the stent started to deploy fine but midway through the lesion, the rotating wheel allegedly did not rolled out smoothly.It was further reported that the stent was allegedly found to be twisted and could not be advanced.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025) h11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a stent placement procedure in the left proximal superficial femoral artery, the stent started to deploy fine but midway through the lesion, the rotating wheel allegedly did not rolled out smoothly.It was further reported that the stent was allegedly found to be twisted and could not be advanced.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent or the delivery system were not available for evaluation.X-ray images provided for evaluation show a stent placed in the left femoral artery.A twisted section of the stent can be confirmed, proximal and distal to the twisted segment the stent is properly expanded.However, the proximal and distal ends of the stent are not visible on the image, a guidewire is in place.Based on the information available, the stent placed in the patient is confirmed to be twisted.As the delivery system was not retuned the reported issues using the thumb wheel could not be verified.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling applicable for this product was reviewed.Correct deployment was found to be addressed, e.G., the instruction for use states "confirm that the introducer sheath is secure and will not move during deployment.(¿) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.(¿) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position." in addition, the instruction for use states: "predilation of the lesion should be performed using standard techniques." and "post stent expansion with a pta catheter is recommended." h10: d4 (expiration date: 10/2025).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: LIFESTENT VASCULAR STENT
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19663631
• Report Number: 9681442-2024-00169
• Device Sequence Number: 15181899
• Product Code: NIP
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANHX2282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Race: Black Or African American