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

Catalog Number EX062003L

Device Problems Break (1069); Positioning Failure (1158); Difficult to Insert (1316)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure via contralateral femoral artery, the stent allegedly failed to deploy.It was further reported that the device allegedly had difficulty in insertion.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 a broken wire inside the grip which made a deployment impossible.The distal part of the system was found in good condition and during testing the system could be easily inserted into a system compatible 6f introducer sheath so that an indication for difficult insertion through the introducer could not be identified.Superficial kinks were found on the black proximal sheath but it was not known when these were caused, and they were considered as not related to the deployment failure because the phynox tube underneath was found without damage.The investigation leads to confirmed result for break of a force transmitting component, and deployment failure.The vessel was not particularly tortuous but calcified, the lesion was pre dilated, and system compatible introducer and guidewire were being used.The guidewire was running smoothly inside the system, and the user felt increased friction during insertion of the device; the guidewire was running smoothly inside the system.Based on available information, the investigation is closed with confirmed result for break of a force transmitting component and failure to deploy.A definite root cause for the reported event could not be determined.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.' holding and handling of the system throughout deployment was found sufficiently describe, in particular the instructions for use state: 'gently hold the stability sheath at or proximal to the orange marking and maintain it straight and under tension throughout the procedure.' the instructions for use further state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regard to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' under required materials the instructions for use state: '6f (2.0 mm) or larger introducer sheath, 0.035 inch (0.89 mm) diameter guidewire.' (expiry date: 01/2024).

• Brand Name: LIFESTENT SOLO 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: 15649122
• MDR Text Key: 306649921
• Report Number: 9681442-2022-00310
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519003900
• UDI-Public: (01)04049519003900
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX062003L
• Device Lot Number: ANGN3397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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
• Patient Age: 83 YR
• Patient Sex: Male