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

Catalog Number	EX062003CL
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a stent placement procedure, the catheter was allegedly bent or frayed near the handle directly out of the package.It was further reported that the wire allegedly had some resistance going through the catheter and was allegedly found to be damaged.The procedure was completed using another device.There was no patient contact.
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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2025).H11: 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
It was reported that prior to a stent placement procedure, the catheter was allegedly bent or frayed near the handle directly out of the package.It was further reported that the wire allegedly had some resistance going through the catheter and was allegedly found to be damaged.The procedure was completed using another device.There was no patient contact.
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 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 issues.Investigation summary: the sample was returned for evaluation.The returned sample was found kinked at the proximal end close to the grip, and with break at the kink axis; during evaluation testing a system compatible 0.035" guidewire could not pass the broken section.The investigation leads to confirmed result for kink, break, and failure to advance.A system compatible 0.035" guidewire was in use, the system could be flushed without issue, a damage was not identified prior to unpacking.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter kink and break close to the grip leading to 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: 'keep the device as straight as possible following removal from the packaging and while inserted in the patient' and 'do not rotate the grip while extracting the stent system from the tray'.The instructions for use further state: '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 must not be used'.Under required materials the instructions for use state a 0.035" guidewire.H10: d4 (expiration date: 02/2025).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 SOLO 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: 18299305
• Report Number: 9681442-2023-00393
• Device Sequence Number: 17930265
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: EX062003CL
• Device Lot Number: ANHP1685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/12/2024
• 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