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

Catalog Number	AVSM08080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure in the cephalic arch via the left brachial cephalic fistula, the stent allegedly got stuck in the sheath after it was deployed.It was further reported that to get the stent out, the sheath was removed with the stent over the wire.The procedure was completed by using another device.There was no reported patient injury.
Additional 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.The investigation of the reported event is currently underway.H10: d4: (expiry date: 09/2025).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.
Event or Problem Description
It was reported that during a stent graft placement procedure to treat multiple thrombectomies and repeat stenosis within the cephalic arch via the left brachial cephalic fistula, the stent allegedly got stuck in the sheath after it was deployed.It was further reported that the delivery system was removed with the introducer sheath as a single unit and another introducer sheath was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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 8f stent delivery system was returned for evaluation.The stent was deployed and missing as it was placed in the patient.The stent catheter was found introduced in an 8f introducer sheath.The delivery system and the introducer sheath were significantly contaminated with coagulated blood.However, the introducer sheath could be removed from the delivery system without causing any damages.Based on evaluation of the delivery system no indication for a product cause could be found.The tracking anatomy was reported not being tortuous or calcified and there were no reported issues during tracking the device to the target lesion.The stent was placed to treat a stenosis in the cephalic arch.Therefore, the investigation of the reported issue is closed with inconclusive result.Based on evaluation of the sample returned no indication for a product or manufacturing related cause could be found.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Regarding accessories to be used the instruction for use states: "the covera¿ vascular covered stent device is an over-the-wire delivery system.The delivery system is compatible with 0.035 inch guidewires and 8f or 9f introducer sheaths." 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." expiry date: 09/2025.H11: b5, 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.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: 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: 18928710
• Report Number: 9681442-2024-00052
• Device Sequence Number: 18482811
• Product Code: PFV
• UDI-Device Identifier: 00801741106309
• UDI-Public: (01)00801741106309
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AVSM08080
• Device Lot Number: ANHW3300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown