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

Catalog Number EX061703C

Device Problems Occlusion Within Device (1423); Dent in Material (2526); Material Torqued (2980); Material Twisted/Bent (2981)

Patient Problems Occlusion (1984); Vascular System (Circulation), Impaired (2572)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # (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 two stents were placed in overlapping technique in the sfa and that the distal stent was found dented three days after placement.Furthermore, the vessel was found occluded.Thrombectomy, balloon dilation, further stent placement and lysis were performed to treat the patient.After lysis the patient was found free of thrombus and free of stenosis.This complaint addresses the stent in distal position.

Manufacturer Narrative

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 all specifications prior to shipment.There is no indication for a manufacturing-related failure.Based on the images and video clips provided it is confirmed that two stents were placed in overlapping manner and that the stent in distal position was found twisted three days after placement.The stented section was found occluded.Potential factors that could have led or contributed to the event reported have been evaluated.Therefore previous investigations of similar complaints have been reviewed.A root cause analysis for the failure mode of twisted stents has been previously performed to determine the root cause for this kind of event.Based on the root cause analysis performed, twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Due to the helical structure the stent has an inherent tendency to rotate clockwise upon deployment of the delivery system.The failure mode may occur when this rotational movement is constricted during stent deployment or when rotational forces are applied externally on the stent.There may be also various physical forces, including individual patient factors, contributing to the twisting of a stent in this region.In this case no issues were reported during the initial stent placement.As reported the lesion was pre dilated and post dilated.Based on the information available and the evaluation of the images provided, a definite root cause could not be determined.In reviewing the labeling supplied with this product it was found that the ifu sufficiently describe the correct deployment of the stent.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 (.) 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: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques.' (b)(4).

• Brand Name: LIFESTENT XL VASCULAR STENT
• 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 -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5339713
• MDR Text Key: 34912601
• Report Number: 9681442-2016-00003
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EX061703C
• Device Lot Number: ANZF2962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 55