MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number	5F070601CS
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure.During the procedure, the life stent allegedly fractured reported an unusual loud crunch/pop sound during the process.There was no patient injury was reported.
Additional Manufacturer Narrative
H11: 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.Section a through f ¿ the information provide 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.
Additional Manufacturer Narrative
H11: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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: neither sample nor images provided which leads to inconclusive result.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout the procedure was found sufficiently described.In particular the instructions for use state: confirm that the introducer sheath is secure and will not move during deployment.Hold the green stability sheath.Do not hold or touch the brown moving sheath.' and 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' regarding access/ accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.Insert a guidewire of appropriate length (table 2) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter.' the lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenostic lesions.In the native superficial femoral artery (sfa) and popliteal artery.B5, g3, h6 (device, conclusion).Section a through f: the information provide 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
On (b)(6) 2025, a patient underwent a stent placement procedure.During the procedure, the life stent allegedly fractured upon deployment.The surgeon reported an unusual loud crunch/pop sound during the process.There was no patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the lot history records 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 a definite root cause could not be identified.Investigation summary: the physical sample was not returned for evaluation.An x-ray photo was provided showing a stent placed in the iliac region.The photo contains two yellow arrows pointing to the two ends of the deployed stent, without any description of what these arrows are intended to indicate.No stent fracture could be identified.The quality and resolution of the image are very limited.The image does not contain any information that could contribute to the investigation of the reported issue.Therefore, the result of the investigation is 5f introducer with 0.035" guidewire were used for access, the vessel was not tortuous but calcified, and the lesion was pre dilated.The issue reportedly was not caused by a partial stent deployment.During deployment, the system was gently held at the stability sheath and kept stationary; the user did not experience a force increase.The product was used off label.Based on the investigation of the provided information, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labelling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout the procedure was found sufficiently described.In particular the instruction for use state: confirm that the introducer sheath is secure and will not move during deployment.(.) hold the green stability sheath.Do not hold or touch the brown moving sheath.And do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pta the instruction for use state: pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' regarding access/ accessories the ifu state: gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of appropriate length (table 2) and 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter (.).The lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenostic lesions (.) in the native superficial femoral artery (sfa) and popliteal artery (.).E1, g2, g3.Section a through f: the information provide 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
On (b)(6) 2025, a patient underwent a stent placement procedure.During the procedure, the life stent allegedly fractured upon deployment.The surgeon reported an unusual loud crunch/pop sound during the process.There was no patient injury.

• Brand Name: LIFESTENT 5F 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: 22333932
• Report Number: 9681442-2025-00197
• Device Sequence Number: 8994333
• Product Code: NIP
• UDI-Device Identifier: 00801741120251
• UDI-Public: (01)00801741120251(17)271001(10)ANJX0213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2025

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: 5F070601CS
• Device Lot Number: ANJX0213
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 09/01/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/09/2025
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White