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

Model Number EX062003CL

Device Problems Failure to Advance (2524); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.(expiry date 07/2020).

Event Description

It was reported that during a stent deployment procedure, the stent allegedly failed to track through the anatomy to the desire treatment site.

Manufacturer Narrative

Manufacturing review: based on the lot history review the used product 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.Investigation summary: based on the investigation of the returned catheter sample a failure to advance could be confirmed.The sample was found with locked safety slider and fully loaded stent, however, the stent including inner catheter was found shifted some millimeters, which indicates that an outer friction force was present leading to the release motion.The system was found bloody on inner and outer surface which led to the conclusion that it was inside patient as reported, and that the guidewire was fully inserted.The tip was found invaginated which may be a further indication for tracking difficulty.A manufacturing related issue leading to the reported event could not be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported failure could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addressed the potential risk.The ifu states: 'flush the inner lumen of the stent system with heparinized normal saline prior to use.', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage, the ifu states: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' the ifu demands for 6f introducer sheath, and a 0.035" guidewire.H11: b5, h3, h6 (eval code & desc- method 1, results 1, conclusion 1).H11: after further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.H11:section a through f - 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 during a stent deployment procedure, the stent allegedly failed to track through the anatomy to the treatment site.

• 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
• MDR Report Key: 7982303
• MDR Text Key: 124565156
• Report Number: 2020394-2018-01921
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• 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
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCU1506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1