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

Catalog Number	5F051503CS
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
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 sample was returned for evaluation.The returned sample was found with unused deployment mechanism, and with locked safety.At the distal end compressive crinkles were found on the stent sheath in three different positions which may indicate insertion difficulty.But it was not known when these crinkles were caused.During evaluation testing, the system could be inserted through a system compatible 5f introducer sheath but friction increase was felt when the crinkles reached the introducer lip.The investigation leads to confirmed result for failure to advance, and catheter deformation.Pedal access was used which was considered a significant factor.Compressive crinkles were found on the system which may cause insertion difficulty or which may be the result of insertion difficulty; it was not known when these crinkles were caused.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter deformation and failure to advance.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 state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage the instructions for use state: 'keep the device as straight as possible following removal from the packaging and while inserted in the patient.Failure to do so may impede the optimal deployment of the implant.', and 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.' h10: d4 (expiry date: 09/2025) 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 : see h10.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly would not go through the introducer sheath from a pedal artery access site.There was no reported 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: 17659090
• Report Number: 9681442-2023-00310
• Device Sequence Number: 6207936
• Product Code: NIP
• UDI-Device Identifier: 00801741120664
• UDI-Public: (01)00801741120664
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/16/2023

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 Catalogue Number: 5F051503CS
• Device Lot Number: ANGW2300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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