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

Model Number 5F051003CS

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 05/15/2023

Event Type  malfunction  

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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent 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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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 Description

It was reported that during an stent deployment procedure, the tip of the shaft allegedly broke off.The stent was not deployed.There was no reported patient injury.

Event Description

It was reported that during a stent deployment procedure via right antegrade access, the tip of the shaft allegedly broke off.It was further reported that the stent could not be pushed further than the end of the sheath, and the stent was not deployed.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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products 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 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 was found with unused deployment mechanism and with loaded stent.During testing, a system compatible 0.035" guidewire could be fully, and successfully inserted, and the system could be successfully inserted into a 5f introducer sheath so that the reported insertion failure could not be re produced.The inner catheter cardan tube was found broken inside the stent sheath and the distal end including tip was missing which leads to confirmed result for break and cascading detachment.System compatible 5f introducer with 0.035" guidewire were used for access, and the system could be successfully flushed.Based on the information available the investigation is closed with confirmed result for inner catheter break and 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: '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'.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'.The instructions for use further states: 'prior to use flush the guidewire lumen of the stent system with normal, sterile saline until saline exits the tip of the system'.H10: b5, d4 (expiration date: 05/2025), g3, h6 (device) h11: h6 (result) 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.

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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products 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 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 was found with unused deployment mechanism and with loaded stent.During testing, a system compatible 0.035" guidewire could be fully, and successfully inserted, and the system could be successfully inserted into a 5f introducer sheath so that the reported insertion failure could not be re produced.The inner catheter cardan tube was found broken inside the stent sheath and the distal end including tip was missing which leads to confirmed result for break and cascading detachment.System compatible 5f introducer with 0.035" guidewire were used for access, and the system could be successfully flushed.Based on the information available the investigation is closed with confirmed result for inner catheter break and 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: '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'.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'.The instructions for use further states: 'prior to use flush the guidewire lumen of the stent system with normal, sterile saline until saline exits the tip of the system'.H10: d4 (expiration date: 05/2025).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 deployment procedure via right antegrade access, the tip of the shaft allegedly broke off.It was further reported that the stent could not be pushed further than the end of the sheath, and the stent was not deployed.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: 17231114
• MDR Text Key: 318371764
• Report Number: 9681442-2023-00249
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119910
• UDI-Public: (01)00801741119910
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5F051003CS
• Device Catalogue Number: 5F051003C
• Device Lot Number: ANGS0796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• 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