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

Catalog Number EX071503C

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  Injury  

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 ten months after stent placement to treat the mildly calcified aso in the right lower limb with contralateral access via left femoral artery, the stent allegedly fractured on three different locations.Reportedly, medical intervention was required to place another stent to cover all the fractures from the stent previously placed.As a result, the patient's vascular flow was restored.

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.No additional complaint has been reported for this lot number previously.Investigation summary: based on two images provided it was confirmed that two stents had been placed overlapping and that both stents were found twisted.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 ten months after overlapping stent placement to treat the mildly calcified aso in the right lower limb with contralateral access via left femoral artery, the stent allegedly fractured and torqued.A medical intervention was required to place another stent to cover all the fractures from the stents previously placed.As a result, the patient's vascular flow was restored.

• 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: 7143361
• MDR Text Key: 95655190
• Report Number: 9681442-2017-00313
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001661
• UDI-Public: (01)04049519001661
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2017
• Device Catalogue Number: EX071503C
• Device Lot Number: ANZJ2828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR