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

Model Number AVSM10060

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problems Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that fourteen days post stent placement procedure through cephalic arch, the stent was allegedly blocking off the basilic vein.It was further reported that the patient allegedly experienced pain and swelling in the arm and surgical intervention was performed.Reportedly the stent had to be removed and the procedure was completed using another device.The current status of the patient is unknown.

Manufacturer Narrative

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.The investigation of the reported event is currently underway.D4 (expiration date: 10/2023).

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.Investigation summary: the physical sample was returned for evaluation.The cut out covered stent was returned; but the condition after the mechanical cut out did not reflect the condition inside patient.The lumen of the covered stent was found open, and a verification of the condition inside patient was not possible.Images demonstrating the stent inside the vessel were not provided which leads to inconclusive evaluation result.Based on evaluation of the returned cut out covered stent the condition inside the vessel could not be verified which leads to inconclusive evaluation result.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.The instruction for use closely describes holding and handling of the system throughout deployment, in particular the instruction 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 (segment between left and right hand on illustration) relaxed and avoid tension.' a covered stent diameter selection table describes the relationship between covered stent diameter and reference vessel or graft diameter.In regards to pta the instruction for use state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.' under potential complication and adverse events the ifu state, but is not limited to: pain, thrombotic occlusion, restenosis of the target lesion requiring reintervention, insufficient covered stent expansion.H10: b2, d4 (expiration date: 10/2023), g3, h6 (patient, device) h11: h6 (method, 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.H3 other text : see h10.

Event Description

It was reported that fourteen days post stent placement procedure through cephalic arch, the stent was allegedly blocking off the basilic vein.It was further reported that the patient allegedly experienced pain and swelling in the arm and surgical intervention was performed.Reportedly the stent had to be removed and the procedure was completed using another device.The current status of the patient is unknown.

• 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 Key: 14194104
• MDR Text Key: 290058332
• Report Number: 9681442-2022-00127
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• 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: 05/07/2022

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
• Device Operator: Health Professional
• Device Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANFX0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/11/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male