MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1400250-08
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226)
Date of Event	07/18/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017: above rbp.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal left anterior descending (dlad).On (b)(6) 2025, an unspecified stent was implanted.Then 2.5x8mm nc trek neo balloon dilatation catheter (bdc) was advanced to the distal end of the stent without issue for post dilatation.The balloon was inflated above the rated burst pressure of 18 three times to 18, 23 and 25 atmospheres (atm).The bdc was removed with no imaging performed.Another unspecified balloon was advanced for post dilation for the proximal end of the stent.Then imaging was performed when a perforation was noted at the distal end of the implanted stent and cardiac tamponade was observed.Therefore, 2 covered unspecified stents were placed to treat the perforation, a sternotomy was performed, an impella device was placed and pericardiocentesis was performed, which resulted in additional hospitalization as this was initially an out patient procedure.On (b)(6) 2025, the patient died.In the physicians opinion, the aggressive inflation of the nc trek caused both the perforation and tamponade which led to the patient death.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided and the medical review, it is possible that the instructions for use (ifu) violation of overinflating the balloon may have contributed to vessel stress during the procedure; however, a definitive cause for the relationship of over inflating the balloon to the patient effects of perforation of vessels, cardiac tamponade and death could not be determined.Additionally, the reported patient effects of surgical intervention, unexpected medical intervention and hospitalization appear to be related to circumstances of the procedure.The reported patient effects of perforation, cardiac tamponade and death are listed in the coronary dilatation catheters (cdc), nc trek neo, instruction for use as known patient effects.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK NEO¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22754749
• Report Number: 2024168-2025-08287
• Device Sequence Number: 8599005
• Product Code: LOX
• UDI-Device Identifier: 08717648232398
• UDI-Public: (01)08717648232398(17)280331(10)50421G1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1400250-08
• Device Catalogue Number: 1400250-08
• Device Lot Number: 50421G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White