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	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the optical coherence tomography (oct) assessment of the lesion, the optis next integrated system showed a stent of 15mm long was needed to treat the lesion in the mid left anterior descending coronary artery (lad).When the stent system was advanced to the lesion, it was noted that the stent would be too short for the lesion; therefore, the stent system was removed, undeployed.An 18mm stent system was then advanced to the lesion and used without issue.There was no adverse patient effect or clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the finished product device history record and the corrective action tracking system for the web (catsweb) database for this serial number revealed no nonconforming material records (ncmr)/exceptions).From reviewing the raw data, it seems like the stent landing zone markers in the sizing screen were heavily relied on when it was reported that the system has showed a stent of 15mm long was needed, which was too short.The stent landing zone markers are a good starting point to determine the appropriate stent size.However, in this case, some of the calcified area of the vessel were not within the stent landing zone markers.This needs to be accounted for in order to achieve the right stent size.There is no evidence of software issue in this case.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: 16943127
• Report Number: 2024168-2023-05233
• Device Sequence Number: 3340088
• 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): 06/28/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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