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

Catalog Number 5F051701C

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the left superficial femoral artery via crossover approach, the stent was allegedly failed to deploy.It was further reported that the guidewire allegedly got stuck while trying to retract the stent delivery system.The procedure was completed by using another device.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 physical sample was returned for evaluation.The returned delivery system was found in used condition, the stent was found loaded, and a guidewire was found stuck inside the system.Inside the grip, the proximal end of the cardan tube including proximal sheath was found significantly kinked, which prevented successful stent deployment.The guidewire getting stuck was considered a cascading issue.The vessel was heavily calcified but not tortuous, a 6f introducer and a 0.018 inch guidewire were used for access, and a force increase was not felt during deployment attempt.The system was correctly held at the introducer.Based on the evaluation of the returned sample and the information available, the investigation is closed confirmed that a deformation of the inner catheter leading to the reported failure to deploy the stent and its cascading event.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".Correct handling of the system throughout deployment was found described.Particularly, the instructions for use states: "'hold the green stability sheath.Do not hold or touch the brown moving sheath.Regarding pta the instructions for use states: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended".The instructions for use further states: "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 (table 3) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter'' and "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." h10: d4 (expiry date: 02/2025).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.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: 17963239
• MDR Text Key: 326019984
• Report Number: 9681442-2023-00348
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119866
• UDI-Public: (01)00801741119866
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/12/2023

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: 5F051701C
• Device Lot Number: ANGP0674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/19/2023
• 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