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

Catalog Number	AVSM10040
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stent graft placement procedure in the right forearm, while pulling the catheter after deployment, it allegedly got stuck in stent and could not be removed.It was further reported that the delivery system was allegedly cut outside the patient.Reportedly the patient was referred to vascular surgeon.The current status of patient is unknown.
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: 02/2025).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 in the right forearm, while pulling the catheter after deployment, it allegedly got stuck in stent and could not be removed.It was further reported that the delivery system was allegedly cut outside the patient.Reportedly the patient was referred to vascular surgeon.The current status of patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 delivery system was returned for evaluation with the safety lock slider locked but with the covered stent completely deployed and missing.The inner catheter was cut off and not returned with sample.The reported issue cannot be re produced which leads to inconclusive results.It was reported that the procedure was sheathless, the tracking vessel was tortuous, the lesion was pre-dilated and the device was flushed before use.The diameter of the guidewire used was not specified.The returned sample came with the device still locked and it is not clear how the user deployed the stent without unlocking the device but it known that excessive deployment force would have been needed to deploy the stent without unlocking the device.Irregular deployment could be a further contributing factor to this issue which can lead to struts protruding into the vessel.Based on information available and the evaluation of the returned sample, the investigation is closed with inconclusive results for difficult to remove.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Regarding correct deployment the instructions for use states: "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".Based on the instructions for use material required for a procedure using the covera vascular covered stent are 0.035 inch guidewire of appropriate length, introducer sheath with appropriate inner diameter.Regarding preparation 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".The instructions for use states that "prior to covered stent deployment, the safety lock must be retracted from the locked position into the unlocked position".H11: section a through f ¿ the information provided 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.

• 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: 20062007
• Report Number: 9681442-2024-00254
• Device Sequence Number: 8496290
• Product Code: PFV
• UDI-Device Identifier: 00801741106385
• UDI-Public: (01)00801741106385(17)250203(10)ANHP0666
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2025
• Device Catalogue Number: AVSM10040
• Device Lot Number: ANHP0666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown