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

Catalog Number EX070803JL

Device Problems Premature Activation (1484); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2016

Event Type  malfunction  

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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previously reported similar complaints have been reviewed.Increased friction between guide wire and guide wire lumen as well as increased friction between vessel, introducer sheath and delivery system may cause or contribute to the reported premature stent deployment.Also insufficient flushing of the device as well as the usage of inappropriate accessories may lead to increased friction.A difficult vessel anatomy may be another contributing factor to increased friction.In this case, no information regarding the vessel anatomy, the accessories used and the procedure performed was provided.The reported elongation of the stent is considered a consequence of the premature and uncontrolled stent deployment.On the basis of the information available and as no sample or image was provided, a definite root cause for the reported failure could not be determined.The ifu states: "ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed." and "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used." 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 # p070014.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient or procedural details to bard.

Event Description

It was reported that the vascular stent became prematurely deployed prior to passing a severely calcified lesion in the middle of the sfa via contralateral approach with the safety lock still in place.As a consequence, the vascular stent was placed in this segment of the lesion but the stent elongated 3 cm and jailed the deep femoral artery.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR 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 -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6539887
• MDR Text Key: 74323787
• Report Number: 9681442-2017-00168
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

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: 03/31/2018
• Device Catalogue Number: EX070803JL
• Device Lot Number: ANAQ2170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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