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

Catalog Number EX060801C

Device Problems Positioning Failure (1158); Fracture (1260); Retraction Problem (1536); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records have been made available to the manufacturer.Photos have been provided for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).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 while the health care provider (hcp) was implanting a vascular stent in the common femoral artery, the stent allegedly became stuck.The hcp then noted that part of the stent was cut off and remained inside the patient while the other half remained in the sheath.There was no patient injury reported.

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 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.No additional complaint has been previously reported for this lot number.Investigation summary: two fractured segment of a self expandable bare metal stent were returned by the customer.In addition three photos on an x-ray screen were provided for evaluation.Based on the event information available and the condition of the stent returned, it is conclusive that the stent was partially deployed inside the patient and fractured during removal of the delivery system.This could be confirmed based on photos provided.As the delivery system was not returned for evaluation, the cause for the partial stent deployment could not be reproduced.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently describe the stent deployment procedure.The ifu states: "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.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.(.) deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall and the sheath radiopaque zone is proximal to the proximal stent radiopaque markers." (b)(4).

Event Description

It was reported that during a stent placement procedure intended for the common femoral artery with access through the left superior femoral artery, the stent allegedly failed to completely deploy and became stuck in the sheath.Reportedly, it was observed that the stent had fractured and that half of the stent remained in the sheath and the other half remained inside the patient.Furthermore, there were difficulties removing the delivery system from the patient.No medical intervention was performed to remove the stent fragment and remained inside the patient.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 6736183
• MDR Text Key: 80805047
• Report Number: 9681442-2017-00224
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001418
• UDI-Public: (01)04049519001418(17)170910
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2017
• Device Catalogue Number: EX060801C
• Device Lot Number: ANZI1414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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
• Patient Age: 70 YR
• Patient Weight: 68