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

Catalog Number	EX060603CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Date of Event	03/13/2017
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 / reporter was unable or unwilling to provide any further patient or procedural details to bard.
Event or Problem Description
It was reported that after an unknown period of time post deployment of the stent, the patient experienced pain and swelling of the left leg.Reportedly, the patient would have an allergy to nickel.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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential product and non product related factors which may have caused or contributed to the reported issue have been considered.Allergic reactions may be caused by nickel leaching, however, niti is known as an inert metal composition commonly used in the medical industry.It is unlikely that the patient¿s alleged symptoms (leg pain) would be associated with a nickel allergy; a systemic reaction was not reported.Any concerns regarding the possibility of nickel allergy or other potential complications associated with the stent placement (if any) cannot be evaluated based on the information available and should be discussed directly with the responsible doctor.The patient was recommended to the see the doctor whereupon she confirmed a scheduled appointment.Based on the information available and as a coherence between an allergic reaction of the patient and the implanted nitinol stent could not be verified a definitive root cause for the reported complaint could not be determined.The ifu states that the lifestent vascular stent system is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel, titanium), and tantalum.
Event or Problem Description
It was reported that after an unknown period of time post deployment of the stent, the patient experienced pain and swelling of the left leg.Reportedly, the patient would have an allergy to nickel.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: 6471244
• Report Number: 9681442-2017-00132
• Device Sequence Number: 364614
• Product Code: NIP
• UDI-Device Identifier: 04049519001203
• UDI-Public: (01)04049519001203(17)180205(10)ANAP0904
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2018
• Device Catalogue Number: EX060603CS
• Device Lot Number: ANAP0904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 04/18/2017
• 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: Life Threatening