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

Catalog Number EX062003L

Device Problems Break (1069); Fracture (1260); Retraction Problem (1536)

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

Event Date 05/15/2015

Event Type  Injury  

Event Description

It was reported that during stenting of an sfa occlusion, the sheath of the delivery system broke when the vascular stent was being partially released.During retraction of the deployment system through the introducer sheath, the vascular stent fractured.An additional stent was implanted to cover the fractured segment of the stent and complete the procedure successfully.No patient injury was reported.

Manufacturer Narrative

Although this product is not sold in the us, 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 device history records are being reviewed.The event is currently under investigation.

Manufacturer Narrative

Based on the lot history review the subject device complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.Based on the evaluation of the sample returned it could be confirmed that the deployment mechanism had been actively used until breakage of a force transmitting component occurred when the stent was partially released.The breakage of an additional component in the proximal section of the device was assessed to be a consequence of the increased force during the removal difficulties.Increased friction in the distal section of the delivery system was considered as reason for increased release force and subsequent breakage of the force transmitting component.No indication was found for manufacturing related issues.Potential factors that could have led or contributed to reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.The reported event may be related to difficult anatomical conditions as tortuous or calcified vessels may lead to increased friction.A not performed predilation of the lesion could be also a contributing factor for the reported event.Furthermore, the event reported may be use related as rough handling may lead to friction increase.Based on the information available and the evaluation of the sample returned, a definite root cause for the event reported could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: "do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit." and "predilation of the lesion should be performed using standard techniques.".In this case no predilation was performed.Evaluation completed.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.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4849897
• MDR Text Key: 5931385
• Report Number: 9681442-2015-00067
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: EX062003L
• Device Lot Number: ANYJ0587
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: 88 YR
• Patient Weight: 80