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

Catalog Number EX062003JL

Device Problems Break (1069); Positioning Failure (1158); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the investigation of the returned catheter sample it could be confirmed that the user could only partially deploy the stent.A force transmitting catheter component was found broken inside the grip which made a complete deployment impossible.Excessive release force must have been present leading to break and partial deployment.The grip mechanics were found in good condition.During evaluation severe kinks were found in the proximal section of the system which may have led to blockage during deployment attempt; however, it was not known when and how these kinks were caused.An issue potentially related to production could not be identified.Based on the information available, and the evaluation of the returned catheter sample, a definite root cause could not be identified.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu 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.' in regards to pre dilation and guidewire the ifu states: 'during stent deployment, use the 0.035" guidewire (recommended) for more support depending on vascular anatomy and / or lesion morphology.', and 'predilation of the lesion should be performed using standard techniques.' the ifu further states: 'do not rotate the grip while extracting stent system from tray.', and 'keep the device as straight as possible following removal from the packaging and while inserted in the patient.Failure to do so may impede the optimal deployment of the implant.' (b)(4).

Event Description

It was reported that during a stent placement procedure in the right sfa via access through the left femoral, the stent allegedly failed to deploy.Therefore, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8310396
• MDR Text Key: 135179743
• Report Number: 9681442-2019-00014
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112058
• UDI-Public: (01)00801741112058
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Catalogue Number: EX062003JL
• Device Lot Number: ANCQ2362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• 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