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

Model Number AVSM10060

Device Problem Activation Failure (3270)

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

Event Date 04/21/2022

Event Type  malfunction  

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.Investigation summary: the sample was not returned to the manufacturer for evaluation and images were not provided for review.Based on information available and because the sample was not available for evaluation the reported issue is closed with inconclusive evaluation result.A definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use states "prior to covered stent deployment, unlock the red safety lock (figure 7) by pressing down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible." expiry date: 10/2023.

Event Description

It was reported that during a stent placement procedure, the device allegedly had a activation failure.There was no reported patient injury.

• 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: 15173062
• MDR Text Key: 303331316
• Report Number: 9681442-2022-00231
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANFX3136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/05/2022
• 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