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

Model Number	1012449-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient initially presented with inferoposterior myocardial infarction (mi) due to occluded thrombotic lesion at the circumflex (cx) artery.Treatment was not reported; however, one day later, the patient had complaints of chest pain and ventricular tachycardia and was taken back to the cath lab for a second procedure.This second procedure was performed to treat a lesion in the mid left anterior descending coronary artery with heavy calcification, mild tortuosity and 80% stenosis.The diamondback 360 orbital atherectomy system (oas) therapy was used, followed by the implantation of an unspecified stent.Continuing to treat the predominately fibro-lipidic proximal lesion, a 3.0x15mm nc trek rx balloon dilatation catheter (bdc) was used.The balloon was inflated to 16 atmospheres when a vessel perforation occurred.Balloon inflation was used to treat the dissection.However, in-stent thrombosis occurred with the implanted unspecified stent.The nc trek bdc did not cause or contribute to the micro thrombus.The patient was stable post procedure and compliant with dual antiplatelet drug therapy.The patient experienced two episodes of cardiac arrest related to mi and was treated with cardiopulmonary resuscitation (cpr); however, the patient expired.Per physician, the nc trek bdc did not cause or contribute to the mi or death.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The production record and corrective and preventive 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.The reported patient effect of perforation and death are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as a known patient effect.A conclusive cause for the reported patient effect of perforation of vessels, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.It was reported by the physician that the reported death is unrelated.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: NC TREK
• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20318882
• Report Number: 2024168-2024-11390
• Device Sequence Number: 12728354
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: (01)08717648151873(17)260531(10)30602G1
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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 Expiration Date: 05/31/2026
• Device Model Number: 1012449-15
• Device Catalogue Number: 1012449-15
• Device Lot Number: 30602G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2023
• 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: UNSPECIFIED STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown