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

Model Number	EX061503CS
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during treatment of the left popliteal via right groin access, the stent allegedly failed to deploy using the thumbwheel method.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a dhr review was not performed because the lot number was not known.It was therefore not known whether the alleged issue was potentially related to manufacturing.Investigation summary: based on the investigation of the returned delivery system it was confirmed that the user could not deploy the stent.During evaluation, the system was found with blockage in the catheter section which made successful deployment impossible.An indication for a manufacturing related issue could not be found.Note, the system was returned with partial deployment, but additional information was provided that the stent could not be deployed at all and that the user partially deployed the stent outside patient, after the event.Therefore, the investigation will be closed as confirmed for deployment failure.In this case, the tracking vessel was not tortuous or calcified, and the lesion was pre dilated.A manufacturing related issue was considered; however, based on the sample returned, an indication for a manufacturing related issue could not be determined.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu state: 'examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.' and 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit.' h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during treatment of the left popliteal via right groin access, the stent allegedly failed to deploy using the thumbwheel method.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT STENT SYSTEM
• Common Device Name: BILIARY AND VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9700897
• Report Number: 9681442-2020-00046
• Device Sequence Number: 3147598
• Product Code: FGE
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130792
• 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): 04/30/2020

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: EX061503CS
• Device Catalogue Number: EX061503CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 98