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

Catalog Number EX061001C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer; however a photo was provided and a photo review will be performed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us, but is similar to the lifestent stent system products that are cleared in the us.The 510 k number and pro code for the lifestent stent system products are identified.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 post stent deployment to treat the distal end of the superficial femoral artery, the stent allegedly foreshortened.Reportedly, the stent was intended to expand ten centimeters, but only expanded seven centimeters.There was no reported patient injury.

Event Description

It was reported that post stent deployment to treat the distal end of the superficial femoral artery, the stent allegedly foreshortened.Reportedly, the stent was intended to expand to a length of ten centimeters, but only expanded to a length of seven centimeters.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.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 showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Based on lot history records stents with the correct dimension were used during assembly of this end item lot.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the provided images a stent foreshortening could be confirmed.The images documented the vessel before and after stent placement including digital length measurement.Based on the appearance of the stent strut structure and the digital measurements of the stent a stent foreshortening was confirmed.Potential product and non product related factors which may have caused or contributed to the reported issue have been considered.Based on the information available and the evaluation of the images provided, a definite root cause for the event reported could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'remove slack from the delivery system catheter held outside the patient and verify that the distal and proximal stent ends are distal and proximal to the target lesion confirm that the introducer sheath is secure and will not move during deployment to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1 cm minimum with distal end of the stent apposing vessel wall, deployment continues with the following method.While maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end deployment of the stent is complete when the proximal stent end apposes the vessel wall and the sheath radiopaque zone is proximal to the proximal end of the stent.' furthermore, the ifu states: 'predilation of the lesion should be performed using standard techniques.'.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7198247
• MDR Text Key: 97889638
• Report Number: 9681442-2017-00322
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001432
• UDI-Public: (01)04049519001432
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: EX061001C
• Device Lot Number: ANBU0710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1