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

Catalog Number EX060803JL

Device Problems Fracture (1260); Premature Activation (1484); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

Images were provided and are currently under review.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that during a stent placement of the right distal sfa, the stent allegedly inadvertently released around cfa.The physician also felt resistance when advancing the delivery system.It was further reported that the stent allegedly fractured and the fractured segment remains in the patient.The procedure was completed with another device.The patient was reported as asymptomatic.

Manufacturer Narrative

The catalog number has not been cleared in the us, but is similar to the lifestent solo vascular stent system products that are cleared in the us.Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned catheter sample and the provided images it was confirmed that the deployment mechanism was not in use and that the stent was prematurely released and fractured.An indication for a process related issue could not be identified.A definite root cause for the reported failure could not be determined.Labeling review: in reviewing the applicable labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire remove the delivery system and guidewire together.'.

Event Description

It was reported that during a stent placement of the right distal sfa, the stent allegedly inadvertently released around cfa.The physician also felt resistance when advancing the delivery system.It was further reported that the stent allegedly fractured and the fractured segment remains in the patient.The procedure was completed with another device.The patient was reported as asymptomatic.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7505311
• MDR Text Key: 107959892
• Report Number: 9681442-2018-00058
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110351
• UDI-Public: (01)00801741110351
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: EX060803JL
• Device Lot Number: ANBZ0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention