MAUDE Adverse Event Report: ABBOTT VASCULAR OPTIS¿ INTEGRATED NEXT SYSTEM; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number	1014933
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that the optis next system was used and a run was performed without any error messages or physical issues; however, upon assessing the image it was noted the ai stent landing zone markers were not in the right position on the vessel.Additionally, the length of the area of concern was not correct.The optical coherence tomography (oct) measured a length of 13.4mm long; therefore the decision was made to use an 18mm long stent.When the stent was inserted, it was found to be too short; therefore it was removed before deployment and a 23mm long stent was implanted successfully instead.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Per the software review: there is no evidence of a software issue.From reviewing the raw data, it seems like the stent landing zone markers in the sizing screen were heavily relied on when determining the stent size.The stent landing zone markers and the measurement determined by the software are good starting points and should be treated more as guidance.In this case, as the physician has noted, the complete lesion area was not covered by the initial stent landing zone.The stent landing zone markers can be and should be adjusted to cover the complete area of the lesion.In addition, there are a few factors in this case that may have contributed to the inaccurate initial stent landing zone.First, the raw data shows some blood in the vessel which indicates poor clearing.Second, the position of the guide catheter was too close to (or may have been on) the area of the lesion.These two factors may affect our software¿s detection algorithm.Lastly, reviewing the angio co-registration image shows signs of foreshortening of the vessels.The dark spots of the vessels and the positioning of the oct markers in the angiography indicate some overlap of the vessels.Although this does not directly affect the length measurements determined by our software, this can influence the stent size determination process by the user.Foreshortening can be reduced by imaging the heart and the vessels from different angles.The cause of the reported activation and computer software issue could not be determined.It may be possible that it was a user error.Failure to recognize correct distal features.However, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: OPTIS¿ INTEGRATED NEXT SYSTEM
• Common Device Name: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16947326
• Report Number: 2024168-2023-05246
• Device Sequence Number: 2252249
• Product Code: NQQ
• UDI-Device Identifier: 05415067037145
• UDI-Public: 05415067037145
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K150237
• 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): 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1014933
• Device Catalogue Number: 1014933
• Device Lot Number: 19202882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Unknown