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

Model Number	5F051003CS
Medical Device Problem Codes	Break (1069); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
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 device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).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.
Event or Problem Description
It was reported that during a stent placement procedure in the superficial femoral artery, a piece of the deployment device was allegedly break off and got stuck in the patient.It was further reported that snare and balloon was used to retrieve the piece.Reportedly, the patient ended up with knee amputation.The current status of the patient is unknown.
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 is in used condition without stent, and the inner catheter cardan tube is broken in the mid section of the system, and separated.The pta balloon and 0.018" guidewire that reportedly were used for retrieval were also part of the sample return.Also, images were provided for review.Provided images demonstrate additionally used products on the table after the event.Images demonstrating deployment were not provided so that stent jumping/ malposition cannot be confirmed.The investigation leads to confirmed result for break and detachment of the inner catheter cardan tube.A relatively long 100mm stent was in use, the user did not experience force increase during deployment action, the vessel was calcified, and a 6f introducer was used for access; the lesion was pre dilated.Based on the information available the investigation is closed with confirmed 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 instruction 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 instruction for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instruction 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 instruction 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.' a stent size selection table is part of the instruction for use describing the relationship between reference vessel diameter, and stent diameter.Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 06/2024), g3, h6 (device, method).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.
Event or Problem Description
It was reported that during a stent placement procedure in the superficial femoral artery, a piece of the deployment device was allegedly break off and got stuck in the patient.It was further reported that snare and balloon was used to retrieve the piece.Reportedly, patient ended up with knee amputation.The current status of the patient is unknown.

• 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: 17150480
• Report Number: 9681442-2023-00234
• Device Sequence Number: 20277086
• Product Code: NIP
• UDI-Device Identifier: 00801741120640
• UDI-Public: (01)00801741120640
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5F051003CS
• Device Catalogue Number: 5F051003CS
• Device Lot Number: ANFT2337
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic