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

Catalog Number	EX070603CS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide further patient or procedural details.
Event or Problem Description
It was reported that during retraction through the introducer sheath, the tip of the delivery system catheter allegedly detached.Reportedly, the tip was not removed and remains in the patient.There was no reported patient injury.
Additional Manufacturer Narrative
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 all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device, the reported event could be confirmed.The stent was found to be released completely.A part of the inner catheter with the distal tip was found to be broken and missing.As reported, the detachment occurred during removal of the delivery system and the fragment remains in situ.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The breakage of the tip including a part of the inner catheter may be related to increased friction between guide wire and guide wire lumen.Also a difficult vessel anatomy may contribute to increased friction and subsequent breakage.Reportedly, the tip detached during retraction of the delivery system through the introducer sheath.In this case, no information regarding the vessel anatomy and the procedure performed was provided.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states: "flush the inner lumen of the device with saline prior to use." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." furthermore, the ifu states: "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.".
Event or Problem Description
It was reported that during retraction through the introducer sheath, the tip of the delivery system catheter allegedly detached.Reportedly, the tip was not removed and remains in the patient.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR AND 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: 5959906
• Report Number: 9681442-2016-00243
• Device Sequence Number: 18907460
• Product Code: NIP
• UDI-Device Identifier: 04049519001258
• UDI-Public: (01)04049519001258(17)161128(10)ANYK3334
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: EX070603CS
• Device Lot Number: ANYK3334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 55 YR