MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK NEO RX; NC TREK NEO CORONARY DILATATION CATHETER

Catalog Number	1400325-15
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a short lesion in the proximal left anterior descending (plad) artery.The versaturn guide wire was advanced.Pre-dilatation was performed using a 2.5x12 trek rx balloon dilatation catheter (bdc) followed with the first optical coherence tomography (oct) run in the lad.The 3.25x28mmmm xience skypoint stent was then implanted.The 3.25x15mm nc trek neo bdc was used for post dilatation, however, there was resistance felt at the proximal edge of the xience skypoint stent, due to the bdc not being able to bend the curve of the vessel and after pushing slightly was able to advance to the distal portion of the stent and dilatation was performed without issues.Another oct run was performed to check the placement of the stent and upon evaluation of the oct image, it was noted that there was significant malapposition of the stent and an absence of stent struts on the opposing wall which was confirmed in the longitudinal mode display demonstrating that 2 of the proximal stent struts were prolapsed on one another.The opposing wall of the stent had lifted from the wall causing a >300 micron malapposition.The physician then decided to inflate a 3.5 x12 trek rx balloon proximally in order to ensure appropriate apposition without issues.Another oct run was performed to evaluate the result of the 3.5 balloon inflation.Results demonstrated a complete resolution to the malapposition.The versaturn wire was removed and the case was completed without incidence.Patient was discharged without complication.There was no adverse patient effect and although there was small delay in the procedure, there was no patient harm.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.The additional device referenced in b5 are filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a short lesion in the proximal left anterior descending (plad) artery.The versaturn guide wire was advanced.Pre-dilatation was performed using a 2.5x12 trek rx balloon dilatation catheter (bdc) followed with the first optical coherence tomography (oct) run in the lad.The 3.25x28mmmm xience skypoint stent was then implanted.The 3.25x15mm nc trek neo bdc was used for post dilatation, however, there was resistance felt at the proximal edge of the xience skypoint stent, due to the bdc not being able to bend the curve of the vessel and after pushing slightly was able to advance to the distal portion of the stent and dilatation was performed without issues.Another oct run was performed to check the placement of the stent and upon evaluation of the oct image, it was noted that there was significant malapposition of the stent and an absence of stent struts on the opposing wall which was confirmed in the longitudinal mode display demonstrating that 2 of the proximal stent struts were prolapsed on one another.The opposing wall of the stent had lifted from the wall causing a >300 micron malapposition.The physician then decided to inflate a 3.5 x12 trek rx balloon proximally in order to ensure appropriate apposition without issues.Another oct run was performed to evaluate the result of the 3.5 balloon inflation.Results demonstrated a complete resolution to the malapposition.The versaturn guide wire was removed and the case was completed without incidence.Patient was discharged without complication.There was no adverse patient effect and although there was small delay in the procedure, there was no patient harm.Subsequent to the initially filed mdr, the following information was provided: the access site was radial and there was 90% stenosis.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The complaint summary states that a 3.25 x 28 mm xience skypoint stent was successfully implanted in a proximal left anterior descending artery.A 3.25 x 15 mm nc trek neo was then inserted to perform stent post-dilatation.The nc trek was noted to encounter resistance when entering the proximal portion of the deployed stent.After ¿pushing slightly¿ the nc trek entered the stent and post-dilatation was performed without issue.After post-dilatation, an oct pullback was performed that showed malapposition of the proximal stent, this was confirmed in the provided media (photos) associated with the complaint.Repeat stent post-dilatation was performed with a 3.5 x 12 trek rx, resolving the stent malposition.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3: device returning status update from yes to no.

• Brand Name: NC TREK NEO RX
• Common Device Name: NC TREK NEO CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18319327
• Report Number: 2024168-2023-13942
• Device Sequence Number: 17912636
• Product Code: LOX
• UDI-Device Identifier: 08717648232589
• UDI-Public: 08717648232589
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220634
• 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): 01/16/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 1400325-15
• Device Lot Number: 21117G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTICAL COHERENCE TOMOGRAPHY (OCT); VERSATURN GUIDE WIRE
• Patient Age: 54 YR
• Patient Sex: Male