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

Catalog Number 5F060401C

Device Problems Break (1069); Positioning Failure (1158); Premature Activation (1484); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent was allegedly unable to be 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 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 delivery system was returned for evaluation and found in used condition with a guidewire stuck inside the system; the stent was found completely deployed inside a 6f introducer which was part of the sample return.The inner catheter cardan tube was found broken and detached twice, one segment was left on the wire, and the other segment was found inside the introducer sheath, together with the stent.Inside the grip, the proximal end of the cardan tube the including proximal sheath was found significantly kinked proximal to the slide block which made a successful deployment impossible.Deployment of the stent inside the introducer, stuck guidewire, and break of the cardan tube were considered cascading issues.Based on the investigation completed, it is confirmed that a deformation of the inner catheter leading to the reported failure to deploy the stent and its cascading events.However, a definite root cause for the reported issue 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 pta the instructions for use states: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended".Under required materials the ifu states: "5f (1.67 mm) or larger introducer sheath.0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire".Holding and handling of the system during deployment was found described, in particular the instructions for use state: "hold the green stability sheath.Do not hold or touch the brown moving sheath".The instructions for use further states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." h10: (expiration date: 12/2023).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.

• 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: 17963149
• MDR Text Key: 326394537
• Report Number: 9681442-2023-00347
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119972
• UDI-Public: (01)00801741119972
• 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
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060401C
• Device Lot Number: ANEZ3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• 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