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

Catalog Number	EX060403CS
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	02/08/2017
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 or unwilling to provide any further patient details to bard.
Event or Problem Description
It was reported that the stent was used unsuccessfully to open a twisted stent in the proximal sfa.Reportedly, the delivery system could not cross the twisted area and was removed.Post-dilation with a pta balloon (size 6 x 40 mm) was performed to complete the procedure successfully.The stent was patent after post-dilation and there were no clinical consequences to the patient.There was no reported patient injury.This is the same patient as reported in medwatch report concerning patient (b)(6).
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, the reported positioning issue could not be reproduced.The images document the twisting of a previously placed stent and the post-dilation performed to open the twisted section.On the basis of the evaluation of the returned delivery system, the reported event could not be reproduced.The stent was found to be loaded in the system and the system was found to have not been activated.A patency test with a device compatible guide wire was performed successfully.No defect or deficiency of the device was found which may have led to the reported event.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The event may be associated with a difficult vessel anatomy or challenging stent placement site.As reported, the stent was used to open a twisted stent that was previously placed which represents an-off label use of the device and is considered a contributing factor to the reported event.On the basis of the information available and the evaluation of the sample and the images provided, a definite root cause for the reported event could not be determined.The ifu states: "if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used." and "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." the reported application represents an off-label use of the device.The ifu indicates that the lifestent vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and proximal popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.
Event or Problem Description
It was reported that the stent was used unsuccessfully to open a twisted stent in the proximal sfa.Reportedly, the delivery system could not cross the twisted area and was removed.Post-dilation with a pta balloon (size 6 x 40 mm) was performed to complete the procedure successfully.The stent was patent after post-dilation and there were no clinical consequences to the patient.There was no reported patient injury.This is the same patient as reported in medwatch report concerning patient (b)(6).

• Brand Name: LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6403594
• Report Number: 9681442-2017-00106
• Device Sequence Number: 676021
• Product Code: NIP
• UDI-Device Identifier: 04049519001197
• UDI-Public: (01)04049519001197(17)170922(10)ANZI2986
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/17/2017

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: 09/22/2017
• Device Catalogue Number: EX060403CS
• Device Lot Number: ANZI2986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 05/17/2017
• 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: 78 YR