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

Model Number AVSM08100

Device Problems Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent allegedly failed to deploy.The procedure completed by using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the catheter sample is not available for evaluation.Provided image demonstrates the delivery system tip at the entrance to the body without introducer; the covered stent is not directly visible so that the image does not clearly identify a partially deployed stent, but in combination with the provided information it was concluded that the stent was partially deployed with the system tip being located at the skin access.The investigation leads to confirmed result for incorrect handling leading to migration.The user reportedly did not handle the system correctly, but details about the incorrect handling were not provided; the system was used without introducer, and the vessel was not tortuous/ calcified; the lesion was pre dilated and the system was correctly held at the stability sheath; a force increase was not felt, and the covered stent was not partially deployed.Based on the investigation of the provided information, the investigation is closed as confirmed for incorrect handling leading to malpositioning respectively migration of the stent.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout deployment.Under required material the instructions for use state: '0.035 inch guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system (.) introducer sheath with appropriate inner diameter', and the packaging pictograms indicate the introducer size of 9f.In regards to pta the instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' a covered stent diameter selection table is part of the instructions for use describing the relationship between covered stent diameter and recommended oversizing.Expiry date: 04/2024.Device not returned.

• Brand Name: COVERA VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15665573
• MDR Text Key: 306612177
• Report Number: 9681442-2022-00313
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106316
• UDI-Public: (01)00801741106316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM08100
• Device Catalogue Number: AVSM08100
• Device Lot Number: ANGR1546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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