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

Catalog Number	EX050403CS
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2016
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 / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that a stent was successfully deployed to treat a focal 90% stenosis in the distal sfa/proximal popliteal.During the attempt to remove the delivery system the tip of the delivery system get caught on the stenosis.In order to remove the delivery system the user pulled harder but the artery moved and the user was concerned about tearing the vessel.Therefore, a second wire was advanced and an angioplasty balloon was inflated at the stent waist to create space.Furthermore, the hand piece of the delivery system was removed to disengage the delivery system.Ultimately, a long 7 fr sheath was advanced into the cephalad portion of the stent to provide counter pressure as the delivery system was pulled out.The procedure was completed with the use of an additional angioplasty balloon and a covered stent to treat the remaining stenosis.
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 images provided and the returned device, it can be confirmed that the stent was placed in a narrowed section and that removal difficulties occurred.It is also confirmed that the grip was dismantled and that high force was necessary to finally remove the delivery system from the patient.The difficult removal led to catheter breakage, deformation and subsequent guide wire blockage.The tip including the thin walled guide wire lumen were found in good condition and the images did not show a defect or relation to the tip.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy leading to increased friction during system removal.The usage of inappropriate accessories also may contribute to the reported event as this can lead to friction increase.In this case, the tracking path was reported to be calcified but no difficulty occurred during advancement to the lesion.An insufficient balloon dilation may be another contributing factor to the event.Reportedly, the lesion had been pre-dilated; however, based on the images provided the stenosed section was still significantly narrowed after pre-dilation.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu 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 should not be used." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." also ifu states: "pre-dilation of the lesion should be performed using standard techniques" and "insert a 0.035" diameter guide wire of appropriate length across the lesion to be stented via the introducer sheath." furthermore, the device is contraindicated for patients with a lesion that prevents complete balloon inflation or proper placement of the stent or delivery system.

• Brand Name: LIFESTENT VASCULAR AND BILIARY 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: 5462989
• Report Number: 9681442-2016-00058
• Device Sequence Number: 326111
• Product Code: NIP
• UDI-Device Identifier: 04049519007861
• UDI-Public: (01)04049519007861(17)170220(10)ANZB2883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2016

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: 02/20/2017
• Device Catalogue Number: EX050403CS
• Device Lot Number: ANZB2883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 05/12/2016
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 75