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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
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT Back to Search Results
Catalog Number AVSM09060
Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
It was reported that during a stent graft placement procedure in the right cephalic arch via the right upper arm, after deploying the stent, when attempted to remove the delivery device, the device was allegedly found to be stuck to the proximal end of the stent.It was further reported that the patient experienced pain which required additional sedation.Reportedly, the delivery device was advanced while applying the cork-screw method and was removed with the stent remained in the patient.There was no reported patient injury.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4: (expiry date: 10/2025).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.
 
Manufacturer Narrative
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 with the stent completely deployed and missing.No defect of the delivery system could be identified.In addition, x-ray images respectively, angiograms were provided of the right chest of the patient.The images document dilation of a stenosis in the right cephalic arch using a balloon catheter.An image is showing a stent placed distal to the stenosis.Based on the images malposition of the stent is confirmed.The anatomy was reported not being tortuous or calcified.The stent was intended to be placed in a lesion after dilation using an 8x40mm balloon catheter.As reported the stent was placed to treat an extravasation.A damaged or kinked tip of the delivery system may be another contributing factor for the reported issue.Based on evaluation of the delivery system no indication for a product or manufacturing related cause could be found.Based on evaluation of the sample returned no indication for a product or manufacturing related cause could be found.However, based on x-ray images provided, malposition of the stent could be confirmed.Based on information available, a definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.The reported issue and potential factors regarding difficulties of the delivery system after stent deployment were found addressed.Section 'warnings' of the instruction for use states: "do not use the device in patients where full expansion of an appropriately sized pta balloon catheter could not be achieved during pre-dilation with an angioplasty balloon." regarding precautions the instruction for use states: "stent graft dislodgement may occur during removal of the delivery system; therefore, careful attention should be paid during this portion of the procedure to prevent such occurrences." h10: d4 (expiry date: 10/2025), g3, h6 (device, method).H11: h6 (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 graft placement procedure in the right cephalic arch via the right upper arm, after deploying the stent, when attempted to remove the delivery device, the device was allegedly found to be stuck to the proximal end of the stent.It was further reported that the patient experienced pain which required additional sedation.Reportedly, the delivery device was advanced while applying the cork-screw method and was removed with the stent remained in the patient.There was no reported patient injury.
 
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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 Key18928062
MDR Text Key337962009
Report Number9681442-2024-00051
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/29/2024
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 NumberAVSM09060
Device Lot NumberANHX3244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/30/2024
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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