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

Catalog Number EX062003L

Device Problems Break (1069); Fracture (1260); Misfire (2532)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

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.The catalog number identified in model #/lot # has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The pro code for the lifestent vascular stent products is identified in common device name.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the device allegedly failed to deploy and the device didn¿t go inside the patient.Reportedly, the procedure was accomplished using a competitor device.There was no patient contact.

Event Description

It was reported that the device allegedly failed to deploy, and the device didn¿t go inside the patient.Reportedly, the procedure was accomplished using another manufacturers device.There was no patient contact.

Manufacturer Narrative

Manufacturing review: a manufacturing related root cause was considered, however, 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 the specification prior to shipment.There were no identified manufacturing anomalies or changes which may have caused or contributed to the reported event.There are no additional complaints previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample the alleged failure could not be reproduced.Reportedly, the system was not inside the patient but the deployment system was found actively used, the stent was found partially released and fractured, and excessive load must have been present on the grip mechanics.The disposition of the distal fractured stent end was unknown.Therefore, the investigation was inconclusive.Based on the available information, a definite root cause could not be identified.Labeling review: in reviewing the labeling supplied, the potential issue was found addressed.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.', 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.¿ furthermore, the ifu states that the safety lock slider must be unlocked by pulling it back towards the trigger from the locked position.The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The 510 k number and pro code for the lifestent vascular stent products are identified.(b)(4).

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7034950
• MDR Text Key: 92987568
• Report Number: 9681442-2017-00296
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519003900
• UDI-Public: (01)04049519003900
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2019
• Device Catalogue Number: EX062003L
• Device Lot Number: ANBN3363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Date Manufacturer Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1