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

Catalog Number EX061701C

Device Problems Misfire (2532); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Expiry date 07/2020.No medical records and no medical images were provided to the manufacturer.The lot number for 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 procedure in the femoral artery, the stent allegedly partially deployed.It was further reported that the delivery system was removed and the user had to cut the stent.Furthermore, the stent was allegedly stretched at the treatment site.

Manufacturer Narrative

H10: in reviewing the manufacturing and quality records, it was found that no relevant manufacturing process changes were implemented that could have led to the reported event.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.Based on the investigation of the returned delivery system a partial deployment of the stent could be confirmed.The delivery system was returned in partially activated mode and a stent fragment was returned as a separate piece which further confirmed the statement that the stent was cut off at the proximal end by the user.Images have not been provided so that the alleged stent elongation could not be verified.During evaluation testing the system was found fully functioning on the lab table, however, kinks were found on outer and inner sheath with an axial mutual distance of approximately 20mm which may indicate the reason for a blockage but it was not known when and how the kinks were caused and why there was a distance of 20mm.The investigation will be closed as confirmed for partial deployment.An indication for a manufacturing related issue could not be found.Based on the information available a definite root cause for the event reported could not be determined.In reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states '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 pta the ifu states: 'predilation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.'.Furthermore, the ifu states: 'examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.' h10: b5; d4 (expiry date 07/2020); g4 h11: h3; h6 (results 1, conclusion 1).

Event Description

It was reported that during a stent placement procedure in the femoral artery, the stent allegedly partially deployed.It was further reported that the delivery system was removed and the user had to cut off the stent.Furthermore, the stent was allegedly stretched at the treatment site.

• 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: 8182107
• MDR Text Key: 131064891
• Report Number: 9681442-2018-00222
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001494
• UDI-Public: (01)04049519001494
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061701C
• Device Lot Number: ANCU1798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention