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

Model Number	EX061203CS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device manufacture date 08/2017.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 through the results of a clinical trial, that approximately one month post stent placement, duplex ultrasound demonstrated instent stenosis.No reported intervention was performed.The current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records of this lot were 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.No additional complaint has been previously reported for this lot number.Investigation summary: the sample was not available and images have not been provided.The alleged failure could not be re produced, and a device relation of the re occlusion could not be identified which led to an inconclusive evaluation result.In this balloon study case there was no report of deployment difficulty; pre dilation as well as post dilation were performed.The vessel was mildly calcified prior to stent placement.Based on the investigation performed a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addresses this potential risk by indicating that arterial occlusion/ restenosis of the treated vessel is a potential adverse event that may occur.The correct deployment of the stent is sufficiently described as the ifu states: 'confirm that the introducer sheath is secure and will not move during deployment.Confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment (.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position (.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum (.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.'.The ifu also mentions balloon pre and post dilation: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques'.Pma/510k, device manufacture date (manufacturing date: 03/2017) brand name.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one month post stent placement, duplex ultrasound demonstrated instent stenosis.No reported intervention was performed.The current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records of this lot were 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.No additional complaint has been previously reported for this lot number.Investigation summary: the sample was not available and images have not been provided.The alleged failure could not be re produced, and a device relation of the re occlusion could not be identified which led to an inconclusive evaluation result.In this balloon study case there was no report of deployment difficulty; pre dilation as well as post dilation were performed.The vessel was mildly calcified prior to stent placement.Based on the investigation performed a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addresses this potential risk by indicating that arterial occlusion/ restenosis of the treated vessel is a potential adverse event that may occur.The correct deployment of the stent is sufficiently described as the ifu states: 'confirm that the introducer sheath is secure and will not move during deployment.Confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment (.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position (.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum (.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.'.The ifu also mentions balloon pre and post dilation: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques'.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one month post stent placement, duplex ultrasound demonstrated instent stenosis.No reported intervention was performed.The current patient status is unknown.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one month post stent placement, duplex ultrasound demonstrated instent stenosis.No reported intervention was performed.The current patient status is unknown.New information: it was reported through clinical trial, approximately eight-month post index procedure, angioplasty was performed and identified 90% stenosis at the target lesion.It was further reported that a sent graft was placed to treat the lesion.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records of this lot were 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.No additional complaint has been previously reported for this lot number.Investigation summary: the sample was not available and images have not been provided.The alleged failure could not be re produced, and a device relation of the re occlusion could not be identified which led to an inconclusive evaluation result.In this balloon study case there was no report of deployment difficulty; pre dilation as well as post dilation were performed.The vessel was mildly calcified prior to stent placement.Based on the investigation performed a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addresses this potential risk by indicating that arterial occlusion/ restenosis of the treated vessel is a potential adverse event that may occur.The correct deployment of the stent is sufficiently described as the ifu states: 'confirm that the introducer sheath is secure and will not move during deployment.Confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment (.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position (.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum (.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.'.The ifu also mentions balloon pre and post dilation: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques'.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7903785
• Report Number: 9681442-2018-00175
• Device Sequence Number: 11189392
• Product Code: NIP
• UDI-Device Identifier: 04049519001289
• UDI-Public: (01)04049519001289
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2019

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: 03/10/2019
• Device Model Number: EX061203CS
• Device Catalogue Number: EX061203CS
• Device Lot Number: ANBQ1642
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 01/15/2019; 06/24/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/08/2018; 02/11/2019; 06/27/2019
• 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: Other
• Patient Age: 49 YR
• Patient Weight: 101