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

Catalog Number 5F061503CS

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure to treat superficial femoral arterial occlusion via right common femoral artery access and over the left superficial femoral artery, the wheel wire wasn't connected to the inner sheath.So, as they were spinning the wheel, the stent allegedly wouldn't deploy.It was further reported that upon removal, only the outer sheath including handle allegedly came out; then the inner sheath including non-deployed stent were removed.The procedure was completed by using another device.There was no reported patient injury.

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 returned sample was found with used deployment mechanism, and with loaded stent.The proximal force transmitting sheath was found broken at the proximal end which made a successful deployment impossible.Furtherly, the metal inner catheter cardan tube was found broken close to the grip which confirmed that the user had to remove the inner assembly separately.A wheel wire/tether issue could not be identified.System compatible 6f introducer/ 0.014" guidewire were used for access, the lesion was pre dilated, and the vessel was not tortuous but calcified.Based on the investigation of the provided information, the investigation is closed as confirmed for deployment failure and break of inner catheter /proximal sheath close to the grip.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 state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' regarding access/ accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.Insert a guidewire of appropriate length and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter.' the instructions for use further state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.', and '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.' h10: d4 (expiration date: 03/2026).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.

• 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: 18244645
• MDR Text Key: 330671362
• Report Number: 9681442-2023-00388
• 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
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANHQ0898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 64 KG