MAUDE Adverse Event Report: ABBOTT VASCULAR PROSTAR XL SUTURE-MEDIATED CLOSURE; VESSEL CLOSURE SUTURE

Model Number	12322-01
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code 1494 - indications for use.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was an arteriotomy closure of the mild right common femoral artery using a prostar xl after a fenestrated endovascular aneurysm repair (fevar) procedure using a 16f sheath.Reportedly, the prostar xl was successfully preflushed.After insertion into the vessel, there was no bleedback from the marker lumen.The device was successfully flushed again and reinserted with no bleedback seen.Two prostyle devices were used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Analysis was performed on the returned device.The reported marker lumen obstruction could not be confirmed as fluid was observed coming out of the marker port while depressing the plunger of the syringe thus indicates the marker lumen and marker port functioned as expected.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It was reported that this was an arteriotomy closure of the mild right common femoral artery using a prostar xl after a fenestrated endovascular aneurysm repair (fevar) procedure using a 16f sheath.It should be noted that the prostar xl instructions for use (ifu): the prostar xl pvs system is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5f to 10f sheaths.In this case, the device was not deployed.It is unknown if the sheath size used in the procedure contributed to the reported difficulty.Based on the returned device analysis, the reported marker lumen obstruction could not be confirmed.It is possible that the device orientation (upside-down or side ways) or, the patient calcification may have contributed to the reported difficulty.However, this cannot be conclusively determined.The subsequent treatment appears to be related to procedure circumstance.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: PROSTAR XL SUTURE-MEDIATED CLOSURE
• Common Device Name: VESSEL CLOSURE SUTURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16285788
• Report Number: 2024168-2023-01093
• Device Sequence Number: 20065966
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: 08717648000621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 03/31/2024
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 2050341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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 Age: 62 YR
• Patient Sex: Male