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

Model Number	1014933
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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.
Event or Problem Description
It was reported that the procedure was performed in the mildly calcified lesion in the left anterior descending artery.An assessment of the lesion was performed with the optis next ultreon system to measure the lesion for stenting.The physician used a combination of the oct image and the co-registration image to decide the length of the stent; the tip of the guide catheter was placed just past the distal marker of the imaging catheter during co-registration.The assessment determined that a 23mm length stent was long enough to cover the area of concern.A 3.0x23mm xience skypoint stent was advanced and deployed without issues; however, the stent was too short for the lesion.A second stent was implanted to cover the target lesion.Per the physician, imaging suggested the wrong length stent.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing noncomformities 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.Based on the information available, the root cause of the reported issue was determined to be unrelated to a software issue.From the review of logs, there is no evidence of software issue.However, reviewing the raw data shows at least a 5mm offset from angio co-registration resulting in the frame indicator and reference frames jumping on the angio image as you move across the pullback (for example from frame 293 to 293, and frame 299 to 300).Possible factors such as foreshortening, overlap between vessels, low frame rate, and not capturing cine may have contributed to this issue.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: 16694626
• Report Number: 2024168-2023-03567
• Device Sequence Number: 6112197
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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