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

Model Number 5F061503CS

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.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.H3 other text : device pending return.

Event Description

It was reported that during a stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter allegedly detached.It was further reported that the several unsuccessful attempts were made to snare the distal tip through the femoral access.Reportedly, the patient had undergone a surgical bypass.The current status of the patient was unknown.

Manufacturer Narrative

H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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.Investigation summary: the sample was returned for evaluation.The returned delivery system was found in used condition without stent, which reportedly had been deployed inside patient.Images were provided demonstrating the broken and detached segments inside the vessel.The inner catheter cardan tube was found broken at the distal end, and a segment of the cardan tube was missing.Images were provided demonstrating the broken and detached segments inside the vessel.The investigation leads to confirmed result for inner catheter cardan tube break and detachment.The bifurcation was extremely tortuous, the anatomy was tight, and the hcp provider considered this a contributing factor.A force increase was not felt, the guidewire was running smoothly inside the system, and the lesion was pre dilated; a slight bent was found on the distal part of the catheter upon removal.Based on the information available the investigation is closed with confirmed result for inner catheter cardan tube break and subsequent detachment.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 (expiry date: 09/2025), g3, h2, h6 (device, method).H11: h6 (result, conclusion).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.H3 other text : see h10.

Event Description

It was reported that during a stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter delivery system was allegedly detached within the superficial femoral artery.It was further reported that several unsuccessful attempts were made to snare the distal tip through the femoral access.Furthermore, the patient had undergone a surgical bypass.Reportedly, after the delivery was removed a slight bent was found on the distal part of the catheter.The current status of the patient was unknown.

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, an image was provided for review.The investigation of the reported event is currently underway.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 Description

It was reported that during a stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter delivery system was allegedly detached within the superficial femoral artery.It was further reported that the several unsuccessful attempts were made to snare the distal tip through the femoral access.Furthermore, the patient had undergone a surgical bypass.Reportedly, after the delivery was removed a slight bent was found on the distal part of the catheter.The current status of the patient was unknown.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Type of Device: 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: 16783532
• MDR Text Key: 313709751
• Report Number: 9681442-2023-00149
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120206
• UDI-Public: (01)00801741120206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 5F061503CS
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANGW2365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/10/2023; 06/07/2023
• Supplement Dates FDA Received: 06/07/2023; 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention