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

Model Number	EX062003CL
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medical device: expiry date 09/2020.
Event or Problem Description
It was reported that during a stent placement procedure to improve luminal diameter in de novo lesion in a tortuous sfa through common femoral access via a contralateral approach, the delivery system was allegedly difficult to track through the anatomy to the target lesion.Further, the stent allegedly failed to deploy.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure to improve luminal diameter in de novo lesion in a tortuous sfa through common femoral access via a contralateral approach, the delivery system was allegedly difficult to track through the anatomy to the target lesion.Further, the stent allegedly failed to deploy.Therefore, another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the user actively used the deployment mechanism but could not deploy the stent.A force transmitting component was found broken which made a stent deployment impossible.The tip was found in good condition, and images/ dicom movies have not been provided so that the alleged tracking difficulty is inconclusive.An indication for a process related issue could not be found.Based on the information available and the evaluation of the returned sample the investigation is confirmed for catheter break.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the stent system and replace with a new unit.' the ifu further 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.', 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 pta the ifu states: 'predilation of the lesion should be performed using standard techniques.' h10: d4 (expiry date 09/2020).

• 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: 8420888
• Report Number: 9681442-2019-00034
• Device Sequence Number: 2228130
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCW3424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR