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

Catalog Number EX051703C

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

A medical image was 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.

Event Description

It was reported that seven working days post stent placement via a contralateral femoral artery approach to treat lower extremity arteriosclerosis obliterans, the stent was allegedly identified as fractured via angiogram.It was further reported that a short stent was allegedly placed at the fracture point.The patient was stable at the conclusion of the second stent placement procedure.

Event Description

It was reported that seven working days post stent placement via a contralateral femoral artery approach to treat lower extremity arteriosclerosis obliterans, the stent was allegedly identified as fractured via angiogram.It was further reported that a short stent was allegedly placed at the fracture point.The patient was stable at the conclusion of the second stent placement procedure.

Manufacturer Narrative

H10: manufacturing review: review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot 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.Investigation summary: video clips and images were provided.Based on the date shown in the video, the recordings were taken on the date of event.However, only the third image is showing placed stents inside the patients vessel.Based on the resolution of the videos a detailed evaluation of the placed stent in particular the integrity of the stent could not be performed.Therefore, an alleged stent fracture could not be confirmed.Based on the information available a definite root cause for the reported event could not be identified.Labeling review: in reviewing the current labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu describes the stent deployment procedure by stating: "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." balloon pre and post dilation is addressed: "predilation of the lesion should be performed using standard techniques." and "post stent expansion with a pta catheter is recommended." 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.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8724461
• MDR Text Key: 148920815
• Report Number: 9681442-2019-00078
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007786
• UDI-Public: (01)04049519007786
• 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: 08/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: EX051703C
• Device Lot Number: ANDN1245
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR