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

Catalog Number EX060803C

Device Problems Break (1069); Positioning Failure (1158); Material Deformation (2976)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent system products are identified in this report.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.The physical sample was returned for evaluation.The returned catheter sample was found with loaded stent and activated deployment mechanism; the stent sheath was found blocked, and a force transmitting component was found broken inside grip which leads to confirmed result for deployment failure.The vessel was not tortuous/ calcified but the system had to cross a kissing stent in the aorta, and during evaluation a one sided kink pattern was found which indicates that the system was in curved configuration and which was considered a factor to friction increase; the lesion was pre dilated.A 0.018" guidewire was used for access.Based on the investigation of the provided information, the investigation is closed as confirmed for failure to deploy.A definitive root cause could not be determined based upon the available information.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.' in regards to accessories the instructions for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire (.).' the instructions for use further state: 'predilatation of the lesion should be performed using standard techniques.' holding and handling of the system throughout deployment was found sufficiently described; in particular the instructions for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' expiry date: 08/2024.

Event Description

It was reported that during a stent placement procedure via common femoral artery in the superficial femoral artery in the right leg, the stent allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 15657014
• MDR Text Key: 305889242
• Report Number: 9681442-2022-00311
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001425
• UDI-Public: (01)04049519001425
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX060803C
• Device Lot Number: ANGR0986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• 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