MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 1012537-40

Device Problems Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported during preparation of the 9.0x40mm absolute pro self-expanding stent system (sess) resistance was felt when removing the stylet.As it was continued to be pulled the stent began deploy.It was noted that the device was not flushed prior to taking out the mandrel.Therefore, a new same size absolute pro was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6- device code 2017 clarifier: incorrect prep.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to remove mandrel was unable to be replicated in a testing environment due to the condition of the returned device.The reported premature activation was able to be confirmed.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 identified no other incidents from this lot.Reportedly, the device was not flushed prior to taking out the mandrel.It should be noted that the absolute pro vascular self-expanding stent system instructions for use (ifu) states: 1.Holding the tip mandrel in place, inject heparinized saline into the lumen through the proximal luer fitting at the end of the housing assembly.Flush until fluid is observed exiting distally near the stent and at the distal end of the outer jacket.2.Gently twist and pull to remove the tip mandrel.If the tip mandrel is not easily removed, do not use the device.3.Continue flushing until fluid is observed exiting at the distal portion of the tip.It is undetermined if the reported deviation of the instructions for use caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during mandrel removal the tip of the device was inadvertently pulled as well; thus resulting in the reported difficult to remove-mandrel and ultimately resulting in the reported premature activation-stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17050917
• MDR Text Key: 316714602
• Report Number: 2024168-2023-05799
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176227
• UDI-Public: 08717648176227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 1012537-40
• Device Catalogue Number: 1012537-40
• Device Lot Number: 1051161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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