MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM; SUTURE MEDIATED CLOSURE

Catalog Number 12773-03

Device Problems Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular Dissection (3160)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that an arteriotomy closure of the scarred right common femoral artery was attempted using a prostyle device after an interventional common femoral artery endarterectomy procedure with a 6f sheath.Reportedly after deployment, there was difficulty removing the device from the patient.Force was applied to remove the device.Once removed, it was noted that the distal sheath broke off at the elbow.A vascular dissection was also noted.A surgical cutdown was performed to remove the separated sheath and repair the vessel.Afterward, manual arterial compression was performed to achieve hemostasis.There was a reported clinically significant delay due to the surgical cutdown.No additional information was provided.

Manufacturer Narrative

D4: primary udi number - a partial udi was provided as the lot number is not known.H6: medical device problem code 2017 clarifier- excessive force the device was not returned for analysis.A review of the manufacturing records and complaint history could not be conducted because the lot number was not provided.The prostyle device was removed with force.It should be noted that the electronic prostyle instructions for use (ifu), states: do not advance or withdraw the preclose prostyle device against resistance until the cause of that resistance has been determined.Excessive force used to advance or torque the perclose prostyle device should be avoided, as this may lead to significant vessel damage and/ or breakage of the device, which may necessitate intervention and/ or surgical removal of the device and vessel repair.In this case, based on the reported information, the use of force was circumstantial due to the difficulties experienced during removal.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related to circumstances of the procedure.The patient effect of dissection is listed in the electronic prostyle ifu as a known adverse event of use of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• 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: 18988133
• MDR Text Key: 338728678
• Report Number: 2024168-2024-03766
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12773-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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