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

Catalog Number 5F060803C

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that during a stent placement procedure in the ostial superficial femoral artery via the crossover femoral access, the deployment system allegedly fractured.It was further reported a fragment of the fractured device allegedly remained in the patient's body.Reportedly, the fragmented piece could not be snared and another stent was used to push it against the vessel wall.The current status of patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2026).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.

Event Description

It was reported that during a stent placement procedure in the ostial superficial femoral artery via the crossover femoral access, the deployment system allegedly fractured.It was further reported a fragment of the fractured device allegedly remained in the patient's body.Reportedly, the fragmented piece could not be snared and another stent was used to push it against the vessel wall.The current status of patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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 physical sample was not available for evaluation.Provided x-ray images demonstrate a radiopaque piece of catheter inside the vessel close to the guidewire; although a clear identification is not possible due to poor resolution the investigation leads to confirmed result for catheter break leading to detachment.The vessel was tortuous and calcified, the lesion was pre dilated, and a force increase was not felt.The system was correctly held at the stability sheath during deployment, the guidewire was not running smoothly inside the system which may indicate a guidewire related issue, and system compatible 6f introducer with 0.018" guidewire were used for access.A manufacturing related root cause was considered.Based on the information available the investigation is closed with confirmed result for break of the inner catheter cardan tube leading to 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: 06/2026).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.H3 other text : device not returned.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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 physical sample was returned for evaluation.The returned catheter sample is in used condition without stent; the inner catheter cardan tube is broken at the distal end, and the distal end including tip is missing.Provided x-ray images demonstrate a radiopaque piece of catheter inside the vessel close to the guidewire; although a clear identification is not possible due to poor resolution the investigation leads to confirmed result for catheter break leading to detachment.The vessel was tortuous and calcified, the lesion was pre dilated, and a force increase was not felt.The system was correctly held at the stability sheath during deployment, the guidewire was not running smoothly inside the system which may indicate a guidewire related issue, and system compatible 6f introducer with 0.018" guidewire were used for access.Therefore, based on the information available the investigation is closed with confirmed result for break of the inner catheter cardan tube leading to 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: 06/2026), g3, h2, h6 (method) h11:.

Event Description

It was reported that during a stent placement procedure in the ostial superficial femoral artery via the crossover femoral access, the deployment system allegedly fractured.It was further reported that a fragment of the fractured device allegedly remained in the patient's body.Reportedly, the fragmented piece could not be snared and another stent was used to push it against the vessel wall.The current status of patient is 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: 18463812
• MDR Text Key: 332299196
• Report Number: 9681442-2023-00421
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120084
• UDI-Public: (01)00801741120084
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060803C
• Device Lot Number: ANHT1029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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