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

Catalog Number 5F060603C

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in left superficial femoral artery, the delivery shaft and the inner tube was allegedly found to be detached while removing.It was further reported that the snare was used to retrieve but the middle part was further detached, and the tip remained in the vessel.Reportedly, another ipsilateral sheath was inserted, and the tip was retrieved.There was no reported patient injury.

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 system products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent system products 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024) 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.

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 system products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent system products are identified in d2 and g4.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 sample was found in used condition without stent that reportedly had been deployed inside patient, and the inner catheter cardan tube was found broken.A mid section of the cardan tube was missing which confirmed that the cardan tube detached a second time, as reported.The investigation leads to confirmed result for inner catheter cardan tube break leading to detachment.The vessel was highly calcified, system compatible 6f introducer with 0.035" guidewire were used for access, and the lesion was pre dilated but several balloons also ruptured.A force increase was felt during deployment.The guide wire was running smoothly, the system was correctly held at the stability sheath, and upon removal a sudden force increase indicating entrapment was not felt.Based on the information available the investigation is closed with confirmed result for break of the inner catheter cardan tube leading to detachment of the segment in the patient¿s vessel.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: b5, d4 (expiration date: 07/2024), g3 h11: h6 (method, result, conclusion) 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 : see h10.

Event Description

It was reported that during an angioplasty procedure in the severely calcified left superficial femoral artery, the delivery shaft and the inner tube was allegedly found to be detached while removing.It was further reported that the snare was used to retrieve but the middle part was further detached, and the tip remained in the vessel.Reportedly, another ipsilateral sheath was inserted, and the tip was retrieved.There was no reported patient injury.

• 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: 18957647
• MDR Text Key: 338306139
• Report Number: 9681442-2024-00060
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120077
• UDI-Public: (01)00801741120077
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 5F060603C
• Device Lot Number: ANFU0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/25/2024
• 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