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

Catalog Number EX061703C

Device Problems Fracture (1260); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problems Thrombosis (2100); Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.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 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.Accordingly, this event has been determined to be mdr reportable.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 an alleged stent fracture was identified under fluoroscopy.Reportedly, the health care provider used a balloon to dilate the fractured stent resulting in good vascular flow.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.Investigation summary: based on the investigation of the provided images a stent twisting was confirmed.The stent was visibly twisted in the height of the lesser trochanter in a curved section.Single stent struts were found fractured in the twisted section which was considered a consequence of the twisting strut stress.The images also documented patient treatment with pta and restored blood flow.Potential factors that could have led or contributed to the reported event have been evaluated.The twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Based on the information available, a definite root cause could not be identified.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu closely describes the stent placement by stating: '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 1cm minimum.(.) with distal end of the stent apposing the 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.' the ifu also mentions balloon pre and post dilation: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' (b)(4).

Event Description

It was reported that an alleged stent fracture was identified in the sfa under fluoroscopy.It was further reported that the patient required hospitalization and surgical treatments with new access to treat the fractured stent, injury to the patient's blood vessel, and thrombosis.Reportedly, the health care provider used a balloon to dilate the fractured stent resulting in good vascular flow.

• 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: 7217303
• MDR Text Key: 98203793
• Report Number: 9681442-2018-00003
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001500
• UDI-Public: (01)04049519001500
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: EX061703C
• Device Lot Number: ANAR0317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR