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

Catalog Number EX071703C

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

No medical records were provided; however, several medical images were provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent vascular stent system products are identified.Expiry date (b)(6) 2019.

Event Description

It was reported that a few minutes post stent deployment procedure in the sfa, there was alleged in-stent restenosis.It was further reported that medical intervention was required to remove the stent surgically.The patient was hemodynamically stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: the device was not returned for evaluation.X-ray images and an x-ray video clip showing the last phase of stent deployment in the patients sfa have been provided for evaluation.The images document the vessel during pre dilation, after pre dilation with stenosis, after stent placement, and during additional balloon dilation.The resolution of the images demonstrating the placed stent was poor so that a device deficiency could not be identified; the single stent struts were not visible.The video clip document the last phase of stent deployment with poor resolution and a device deficiency could not be identified.Therefore, in summary a device relation to the alleged restenosis could not be identified which led to an inconclusive evaluation result.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 addressed 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 was found sufficiently described: '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 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 Description

It was reported that a few minutes post stent deployment procedure in the sfa, there was alleged in-stent restenosis.It was further reported that medical intervention was required to remove the stent surgically.The patient was hemodynamically stable at the conclusion of the procedure.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8118457
• MDR Text Key: 128867050
• Report Number: 9681442-2018-00207
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001685
• UDI-Public: (01)04049519001685
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX071703C
• Device Lot Number: ANBQ0385
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR