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

Model Number	EX061703CS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Reocclusion (1985); Thrombus (2101)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer; however a photo was provided and a photo review will be performed.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 ten days after a stent was deployed to treat an occluded vessel in the left superficial artery, the stent allegedly fractured.Reportedly, additional intervention was required to remove the thrombus in order to successfully place another device.Furthermore, the new device was placed by overlapping the fractured stent and also covering the proximal end of the left superficial femoral artery.As a result, the patient's flow is stabilized and the patient is currently stable.
Event or Problem Description
It was reported that ten days after a stent was deployed to treat an occluded vessel in the left superficial artery, the stent allegedly fractured.Reportedly, additional intervention was required to remove the thrombus in order to successfully place another device.Furthermore, the new device was placed by overlapping the fractured stent and also covering the proximal end of the left superficial femoral artery.As a result, the patient's flow is stabilized and the patient is currently stable.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been previously reported for this lot number.Investigation summary: one image was provided for evaluation with poor resolution.The image demonstrated overlapping stents in the sfa.In one position an irregularity was visible; however, due to poor resolution a further detailed evaluation was impossible.Therefore, the investigation will be closed with inconclusive result.Based on the information available, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the ifu sufficiently addresses the potential risk.The ifu states that 'arterial occlusion/restenosis of the treated vessel' and 'stent fracture' are potential adverse events that may occur.Furthermore, the ifu states: 'cases of fracture have been reported in clinical use of the lifestent vascular stent.Cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture.¿ the stent deployment procedure was found to be properly addressed in the ifu.In regards to balloon dilation the ifu states: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' the ifu further states:' the safety and effectiveness of this device for use in treatment of instent restenosis has not been established.'.

• Brand Name: LIFESTENT STENT SYSTEM
• Common Device Name: ENDOVASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7188113
• Report Number: 9681442-2017-00321
• Device Sequence Number: 1497364
• Product Code: NIP
• UDI-Device Identifier: 04049519000961
• UDI-Public: (01)04049519000961
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: 06/09/2019
• Device Model Number: EX061703CS
• Device Catalogue Number: EX061703CS
• Device Lot Number: ANBT1280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/08/2018
• 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: 81 YR
• Patient Weight: 98