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

Catalog Number 5F061501C

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 09/22/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure to treat the lesion in right superficial femoral artery using the ipsilateral approach, the delivery system allegedly got stuck near the middle of the stent.It was further reported that tip was allegedly detached and remained in the vessel and was subsequently retrieved using snare.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified 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.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.(expiry date: 12/2023).

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: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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.Images/dicoms demonstrating the entrapment were not provided so that the alleged entrapment cannot be confirmed.The returned sample was found with activated system and without stent since the stent had been successfully deployed.The sample confirmed that the inner catheter cardan tube was broken towards the distal end which leads to confirmed evaluation result for catheter break.The stent was released with a 0.014" guidewire without problem, the lesion was not pre dilated and the stent was not properly aligned to the vessel wall directly after deployment.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: '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.' in regards to pre dilation the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.In regards to removal difficulty the instructions for use state: '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: (expiry date: 12/2023).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 a stent placement procedure in the right superficial femoral artery using the ipsilateral approach, after successful stent deployment, the delivery system allegedly got struck near the middle of the stent upon removal.It was further reported that tip was allegedly detached.Reportedly, the tip was retrieved using snare.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12680969
• MDR Text Key: 281221465
• Report Number: 9681442-2021-00565
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120022
• UDI-Public: (01)00801741120022
• 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: 02/09/2022

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: 5F061501C
• Device Lot Number: ANEZ0430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/17/2022
• 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