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U.S. Department of Health and Human Services

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

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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT Back to Search Results
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.
 
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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 Key16415577
MDR Text Key310283442
Report Number9681442-2023-00043
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741136078
UDI-Public(01)00801741136078
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P170042
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAASLE06060
Device Lot NumberANGW2179
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/22/2023
Supplement Dates Manufacturer Received05/25/2023
Supplement Dates FDA Received05/30/2023
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 Number1
Patient SexMale
Patient Weight90 KG
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