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

Model Number EX071203CS

Device Problems Fracture (1260); Difficult to Remove (1528); Misfire (2532)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 11/2020).

Event Description

It was reported that during a stent placement procedure in the iliac vein, the stent allegedly partially deployed and fractured in half.It was further reported that there was difficult retracting the delivery system from the patient but a segment of the fractured stent was removed without incident.An attempt was made to retrieve the remaining fragment was unsuccessful.Reportedly, another stent along with additional balloon dilatation was used to apose the remaining stent fragment to the vessel wall and cover the lesion to complete the procedure.The patient was reportedly stable at the conclusion of the 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 the specification prior to shipment.Investigation summary: based on the investigation of the returned sample a stent fracture could be confirmed.The catheter sample was returned in fully activated condition and a failure/ damage on the delivery system could not be found.The stent was returned as a separate piece in fractured condition.Although a deployment issue could not be found on the returned delivery system it was assumed that a partial stent deployment led to stent fracture as reported.Therefore, the investigation will be closed as confirmed for partial stent deployment.Based on the information available and the evaluation of the sample returned, a definite root cause could not be determined.Labeling review: in reviewing the relevant vascular labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential factors.The ifu state: 'visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' holding and handling of the system throughout the deployment procedure was found sufficiently described.Regarding pta the ifu state: 'predilation of the lesion should be performed using standard techniques.While maintaining site access with a guidewire, remove the balloon catheter from the patient.' the ifu further state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.The intended stent placement in the iliac vein represents an off label use of the device.Based on the ifu supplied with this product, the lifestent xl vascular stent system is intended to improve luminal diameter (.) in the native superficial femoral artery (sfa) and popliteal artery (.).

Event Description

It was reported that during a stent placement procedure in the iliac vein, the stent allegedly partially deployed and fractured in half.It was further reported that there was difficult retracting the delivery system from the patient but a segment of the fractured stent was removed without incident.An attempt was made to retrieve the remaining fragment was unsuccessful.Reportedly, another stent along with additional balloon dilatation was used to apose the remaining stent fragment to the vessel wall and cover the lesion to complete the procedure.The patient was reportedly stable at the conclusion of the procedure.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9215224
• MDR Text Key: 163059053
• Report Number: 9681442-2019-00190
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001319
• UDI-Public: (01)04049519001319
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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 Model Number: EX071203CS
• Device Catalogue Number: EX071203CS
• Device Lot Number: ANCY1517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109