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

Catalog Number EX071203C

Device Problem Fracture (1260)

Patient Problems Occlusion (1984); Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  Injury  

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 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 stent system products are identified.Accordingly, this event has been determined to be mdr reportable.

Event Description

It was reported that three days after a three-stent deployment procedure (one in the right common iliac artery, one in the proximal end of the right superior femoral artery (rsfa), and one in distal end of the rsfa), the stent in the proximal end of the rsfa was allegedly identified fractured.It was further reported that due to the fractured stent, the patient's right lower limb was swelling.Reportedly, unknown medical intervention was attempted but failed due to the poor vascular condition of the patient.As a result, an unplanned amputation of the right lower limb of the patient was performed.Current patient status is unknown.

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: two photos were provided for evaluation.One photo shows the stent reported to be explanted from the patient, the other photo shows a blood clot placed on gauze pad.No x-rays were provided showing the condition of the stent placed inside the patient.Therefore, a fracture of the placed stent as well as an alleged occlusion of the target vessel could not be verified.In addition any relation of an alleged product deficiency to the blood clot shown on the photo could not be determined.Based on information available and as no x-ray images were provided, the reported event could not be reproduced and the investigation will be closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) addresse the potential risk.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 long-term clinical implications of these stent fractures have not yet been established." the ifu sufficiently describes the stent deployment procedure.The ifu states: predilation of the lesion should be performed using standard techniques."; "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 (.) deployment of the stent is complete when the proximal stent end apposes the vessel wall and the sheath radiopaque zone is proximal to the proximal end of the stent.' regarding post dilation the ifu states: "post stent expansion with a pta catheter is recommended.If performed, select a balloon catheter that matches the size of the reference vessel, but that is not larger than the stent diameter itself.".

Event Description

It was reported that three days after a three-stent deployment procedure (one in the right common iliac artery, one in the proximal end of the right superior femoral artery (rsfa), and one in distal end of the rsfa), the stent in the proximal end of the rsfa was allegedly identified fractured.It was further reported that due to the fractured stent, the patient's right lower limb was swelling.Reportedly, unknown medical intervention was attempted but failed due to the poor vascular condition of the patient.As a result, an unplanned amputation of the right lower limb of the patient was performed.Current patient status is unknown.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6853916
• MDR Text Key: 85574807
• Report Number: 9681442-2017-00263
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001647
• UDI-Public: (01)04049519001647
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: EX071203C
• Device Lot Number: ANAV1730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR