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

Model Number	EX072003CL
Medical Device Problem Codes	Premature Activation (1484); Misfire (2532); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional 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 device has been returned for evaluation.The investigation is currently underway.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 or Problem Description
It was reported that during a stent placement procedure for artherectomy, resistance was allegedly felt while tracking the stent to the intended placement site.It was further reported that upon removal of the delivery system, the stent allegedly partially deployed within the sheath.Another device was reportedly used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.A stent delivery system and a stent were returned.Based on the evaluation of the returned sample a premature deployment and a deployment failure could not be confirmed.The stent was found to be completely released, the safety lock was found to be unlocked and the trigger was found to be used completely.No damage could be identified which could have led to the reported issue.Therefore, the investigation will be closed with inconclusive result.A manufacturing related issue could not be identified.Based on the evaluation, a definite root cause for the reported failure could not be determined.In reviewing the labeling applicable for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used." furthermore the ifu states: "visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed." based on ifu the safety lock slider shall be unlocked after tracking and before stent deployment.(b)(4).
Event or Problem Description
It was reported that during a stent placement procedure for artherectomy, resistance was allegedly felt while tracking the stent to the intended placement site.It was further reported that clicking sounds were heard and the stent was still inside the sheath.Upon removal of the delivery system, the stent allegedly prematurely deployed on the table.Another device was reportedly used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7996028
• Report Number: 2020394-2018-01929
• Device Sequence Number: 19276128
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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
• Operator of Device: Health Professional
• Device Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANCT1564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1