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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 AASLE10100
Device Problems Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure in right femoral vein, the stent allegedly failed to deploy.It was further reported cord was broken.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified in udi# has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified in common device name and pma/510k.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.However, photos were provided for review.The investigation of the reported event is currently underway.Udi# expiry date: 10/2023.Device pending return.
 
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 products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified in d2 and g4.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 physical sample was not returned for evaluation.Based on the evaluation of the pictures provided, the slide block, a force transmitting component, was found disconnected from the bonding joint to the proximal sheath, and tether.It is concluded that the slide block getting disconnected from the proximal sheath, led to the reported impossibility to deploy the covered stent.In this case, system compatible introducer sheath and guidewire were use.Based on the investigation of the provided information, the investigation is closed as confirmed for the inability of the bonding joint (tether / proximal sheath / slide block) to withstand tension which led to the deployment failure of the stent and the reported break of the tether.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.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding the precautions prior to deployment, the instructions for use state: 'maintain a stationary hold on the white stability sheath during covered stent deployment.Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath relaxed and avoid tension.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation and accessories, the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and "0.035 inch (0.89 mm) guidewire of appropriate length introducer sheath with appropriate inner diameter and length." d4 (expiry date: 10/2023).H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.
 
Event Description
It was reported that during a stent placement procedure in right femoral vein, the stent allegedly failed to deploy.It was further reported cord was broken.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure in right femoral vein, the stent allegedly failed to deploy.It was further reported cord was broken.The procedure was completed using another device.There was no reported patient injury.
 
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 products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products 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.Investigation summary: the sample was returned for evaluation.Based on the evaluation of the sample and the pictures provided, the slide block, a force transmitting component, was found disconnected from the bonding joint to the proximal sheath, and tether.It is concluded that the slide block getting disconnected from the proximal sheath, led to the reported impossibility to deploy the covered stent.System compatible introducer sheath and guidewire were used.Based on the investigation of the provided information, the investigation is closed as confirmed for the inability of the bonding joint (tether / proximal sheath / slide block) to withstand tension which led to the deployment failure of the stent and the reported break of the tether.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.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding the precautions prior to deployment, the instructions for use state: 'maintain a stationary hold on the white stability sheath during covered stent deployment.Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath relaxed and avoid tension.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation and accessories, the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and "0.035 inch (0.89 mm) guidewire of appropriate length introducer sheath with appropriate inner diameter and length." h10: d4 (expiry date: 10/2023).H11: section a through f: the information provide by bd represents all 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.
 
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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 Key15332639
MDR Text Key301094381
Report Number9681442-2022-00255
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Reporter Country CodeBR
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAASLE10100
Device Lot NumberANFX3587
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2022
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
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