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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM Back to Search Results
Model Number AVFM08060
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Blood Loss (2597)
Event Date 09/25/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date: 03/2021).
 
Event Description
It was reported that during treatment of the cephalic arc via right arm fistula access, the covered stent deployed properly; however, upon removal, the tip of the delivery system was caught and a break allegedly occurred spanning from the tip to the handle.It was further reported that due to the break, part of the delivery system detached and a snare was required to retrieve it using a new access site, the right femoral.Reportedly, the patient underwent blood loss and required an additional procedure the following day to place a temporary dialysis catheter.The patient is currently stable.
 
Event Description
It was reported that during treatment of the cephalic arc via right arm fistula access, the covered stent deployed properly; however, upon removal, the tip of the delivery system was caught and a break allegedly occurred spanning from the tip to the handle.It was further reported that due to the break, part of the delivery system detached and a snare was required to retrieve it using a new access site, the right femoral.Reportedly, the patient underwent blood loss and required an additional procedure the following day to place a temporary dialysis catheter.The patient is currently stable.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records have been 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: based on the investigation of the returned delivery system a break of the guidewire lumen could be confirmed.The deployment mechanism was found in used condition without covered stent that reportedly had been successfully implanted.The guidewire lumen was found separated and broken in three pieces.An indication for a manufacturing related issue could not be found.As a result of the investigation performed the complaint is confirmed for break of the guidewire lumen.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant ifu for this product, the potential issue was found addressed.Under materials required the ifu state: '0.035 inch guidewire of appropriate length', and 'introducer sheath with appropriate inner diameter'; the packaging labels indicate an introducer size of 8f.The ifu further state: 'flush the delivery system through the luer port at the proximal end of the handle with sterile saline until the saline exits the tip of the system'.H10: d4: (expiry date: 03/2021) 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.
 
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Brand Name
COVERA VASCULAR COVERED STENT SYSTEM
Type of Device
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9215754
MDR Text Key163172219
Report Number9681442-2019-00191
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106514
UDI-Public(01)00801741106514
Combination Product (y/n)N
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAVFM08060
Device Catalogue NumberAVFM08060
Device Lot NumberANDQ2985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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