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

Model Number	5F060403CS
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	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be 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.Device not returned.
Event or Problem Description
It was reported that during an stent placement procedure, the tip of the stent allegedly came off.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: as no specific lot number was reported, the lot history records could not be reviewed.Investigation summary: the sample was not returned to the manufacturer for evaluation and images were not provided for review.Based on information available and as no sample was provided for evaluation, the investigation is 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 risk was found addressed.The instructions for use states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding preparation the instructions for use states: "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.Prior to use flush the guidewire lumen of the stent system with heparinized normal saline until saline exits the tip of the system.Regarding introduction the instructions for use states: "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 across the lesion to be stented via the introducer sheath." h10: b5, g3, h6 (device).H11: b3, d1, d4(medical device catalog number).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 : device not returned.
Event or Problem Description
It was reported that during an stent placement procedure through the right groin through the right leg in the right superficial femoral artery, the tip of the stent system allegedly came off.The device was removed using a snare.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12745568
• Report Number: 9681442-2021-00576
• Device Sequence Number: 5671687
• Product Code: NIP
• UDI-Device Identifier: 00801741120152
• UDI-Public: (01)00801741120152
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/31/2022

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: 5F060403CS
• Device Catalogue Number: 5F060403CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 04/19/2022
• 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: Female