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

Catalog Number AASLE06060

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in left renal artery with t-branch, via right common femoral access, the white part of the shaft was allegedly detached from handle piece at the moment of release, inside the vessel.It was further reported that the detached segment and the device were removed from the patient.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in d2 and g4.H10: 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 delivery system was returned for evaluation and the covered stent was still loaded in the delivery catheter.The safety slider was in the locked position and the deployment mechanism was still in very good functioning condition.The white stability sheath was detached from the kink protection which leads to confirmed results for detachment.It was reported it detached during the procedure, an 8fr introducer was used but the diameter of the guidewire was not specified.The safety lock was still in the locked position, indicating that the customer had not started the deployment procedure.Based on evaluation of the sample, the investigation is closed with confirmed results for detachment.A definite root cause for the reported event could not be established.The intended use of the device represents an off-label use of the device.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.With regards to preparation for use, the instruction for use states "examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed".The intended use of the device represents an off label of the device.The instruction for use supplied with this product states: "the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated".H10: d4 (expiry date: 09/2024), g3 h11: h6 (method, result, conclusion) 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.

Event Description

It was reported that during a stent placement procedure in left renal artery with t-branch, via right common femoral access, the white part of the shaft was allegedly detached from handle piece at the moment of release, inside the vessel.It was further reported that the detached segment and the device were removed from the patient.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: COVERA PLUS 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: 16415577
• MDR Text Key: 310283442
• Report Number: 9681442-2023-00043
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136078
• UDI-Public: (01)00801741136078
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE06060
• Device Lot Number: ANGW2179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male
• Patient Weight: 90 KG