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

Model Number	EX050403CS
Medical Device Problem Codes	Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.However, the lot history records of this lot were 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.Investigation summary: the sample was returned to manufacturer for evaluation.Based on the evaluation of the returned catheter sample a failure to advance could not be confirmed.The sample was found without damage/ deformation, and during evaluation testing the sample could be successfully inserted into a 6f introducer, and could be successfully deployed on the table with each deployment mode independently.An indication for a process related issue could not be found.In this case there was a previously placed stent, and the lesion was extremely calcified.As a result of the investigation performed the complaint is inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.' in regards to pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques.' in regards to accessories the ifu state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath (¿) insert a 0.035" diameter guidewire of appropriate length (see table) across the lesion to be stented via the introducer sheath.' the instruction for use further state: 'recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.' (expiry date: 03/2022).
Event or Problem Description
It was reported that during treatment in the left iliac artery, the stent allegedly failed to advance.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10799327
• Report Number: 9681442-2020-00242
• Device Sequence Number: 3841225
• Product Code: FGE
• UDI-Device Identifier: 04049519007861
• UDI-Public: (01)04049519007861
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 11/06/2020

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: EX050403CS
• Device Catalogue Number: EX050403CS
• Device Lot Number: ANEQ3771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 83