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

Model Number	EX051203CS
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event 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 advancement over the guidewire to the right sfa via a contralateral approach alleged resistance was felt, and the stent allegedly prematurely deployed.Reportedly, another stent delivery system was used to continue the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing related issue was considered, therefore, the lot history 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.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaints have been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample a breakage of the black outer sheath was confirmed.It could be also confirmed that the stent had been successfully deployed by means of the deployment mechanism.Besides the breakage of the outer sheath the system was found in good condition and during evaluation the system could be easily flushed and a system compatible guidewire could be easily inserted and fully advanced.As a result of the investigation performed the complaint was confirmed.However, based on the available information and evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu states: 'if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.' the ifu further states: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the stent system should not be used.' in regards to balloon pre dilation, the ifu states: 'predilation of the lesion should be performed using standard techniques.'.
Event or Problem Description
It was reported that during advancement over the guidewire to the right sfa via a contralateral approach alleged resistance was felt, and a pop sound was felt as if the system came loose from the handle grip.Reportedly, the tracking vessel was calcified and the lesion was not pre dilated.The stent could be deployed without excessive force and the system could be withdrawn without difficulty.Reportedly, another stent delivery system was used to continue the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6853289
• Report Number: 9681442-2017-00261
• Device Sequence Number: 1566595
• Product Code: FGE
• UDI-Device Identifier: 04049519007939
• UDI-Public: (01)04049519007939
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K130792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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 Expiration Date: 11/06/2017
• Device Model Number: EX051203CS
• Device Catalogue Number: EX051203CS
• Device Lot Number: ANZK0677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 88