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

Model Number AVFM10080

Device Problem Material Deformation (2976)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  Injury  

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.(expiration date: 11/2024).

Event Description

It was reported that some time post stent placement, the stent allegedly got buckled.There was no reported patient injury.

Event Description

It was reported that sometime post stent placement, the stent allegedly got buckled.It was further reported that additional intervention was required by placing additional stents for the reported stent buckling.The patient is reported to be stable.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2024), g3.H11: b3, b5, h1, h6 (patient).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.H3 other text : device not returned.

Event Description

It was reported that sometime post stent placement, the stent allegedly got buckled.It was further reported that additional intervention was required by placing the additional stents for the reported stent buckling.The patient is reported to be stable.

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 physical sample was not returned for evaluation.Stent remains implanted.However x-ray images were provided.The x-rays are showing the lesion site prior and post stent placement.Even though a reduced diameter can be determined mid length of the stent, it cannot be determined whether this is due to the anatomy in that area or due to a deficiency of the stent.There were no reported issues during the initial stent placement, the lesion was predilated.It is unknown if the lesion was post dilated right after stent placement.Based on the investigation of the provided information, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Based on the instructions for use covered stent specific events that could be associated with clinical complications include compression, kinking and insufficient covered stent expansion.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." based on the instructions for use the covered stent should be post dilated using an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.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
• 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: 16416118
• MDR Text Key: 310131406
• Report Number: 9681442-2023-00047
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106606
• UDI-Public: (01)00801741106606
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVFM10080
• Device Catalogue Number: AVFM10080
• Device Lot Number: ANGY1228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Hispanic
• Patient Race: White