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

Model Number	5F050803CS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
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, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 expiration date: 11/2024.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 left superficial femoral artery stent placement procedure, during removal of the delivery system, the distal inch and a half of the delivery system was allegedly found to be missing.It was further reported that the segment that broke off was on the wire within the superficial femoral artery and therefore the health care provider snared the tip within the introducer sheath.Reportedly, the tip and the introducer sheath were then removed as a single unit.There was no reported patient injury.
Event or Problem Description
It was reported that during a left superficial femoral artery stent placement procedure, during removal of the delivery system, the distal inch and a half of the delivery system was allegedly found to be missing.It was further reported that the segment that broke off was on the wire within the superficial femoral artery and therefore the health care provider snared the tip within the introducer sheath.Reportedly, the tip and the introducer sheath were then removed as a single unit.There was no reported patient injury.
Additional 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.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 physical sample was not available for evaluation.One provided image of the x-ray screen demonstrates radiopaque material inside a vessel over a wire.The resolution is poor so that an identification is not possible which leads to inconclusive evaluation result.Based on the information available the investigation is closed with inconclusive result.A force increase was not felt upon removal, and it was known that a 6fx45 introducer was in use.Based on the information available the investigation is closed with inconclusive result.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.The instructions for use states: '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 pre dilation the instructions for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use states: '5f (1.67 mm) or larger introducer sheath (¿); 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiration date: 11/2024), g3 h11: h6 (method, result, conclusion) 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 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: 16750334
• Report Number: 9681442-2023-00135
• Device Sequence Number: 8528178
• Product Code: NIP
• UDI-Device Identifier: 00801741120633
• UDI-Public: (01)00801741120633
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/16/2023

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 Model Number: 5F050803CS
• Device Catalogue Number: 5F050803CS
• Device Lot Number: ANFY0475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown