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

Catalog Number EX061503C

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Medical images were provided to the manufacturer.As the lot number for the device was not provided, a review of the device history records has not been performed.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 products that are cleared in the us.The 510 k number and pro code for the lifestent vascular stent products are identified.

Event Description

It was reported that approximately two weeks post stent placement to treat right femoral artery stenosis (12cm lesion) via left femoral artery approach, an angiograph allegedly demonstrated the stent fractured.Reportedly, a second interventional surgical procedure was performed to repair the fracture with a new stent.There was no reported patient injury post procedure.

Event Description

It was reported that approximately two weeks post stent placement to treat right femoral artery stenosis (12cm lesion) via left femoral artery approach, an angiograph allegedly demonstrated the stent fractured.Reportedly, a second interventional surgical procedure was performed to repair the fracture with a new stent.There was no reported patient injury post procedure.

Manufacturer Narrative

H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: based on the evaluation of one image provided a stent fracture could not be confirmed.The resolution of the image was poor so that the stent struts could not be identified which led to an inconclusive evaluation result.Based on review of the provided image the reported stent fracture could not be confirmed and the investigation is closed with inconclusive result.A definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu describe 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 was 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
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8893986
• MDR Text Key: 154303229
• Report Number: 9681442-2019-00141
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001487
• UDI-Public: (01)04049519001487
• 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
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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 Catalogue Number: EX061503C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR