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

Model Number	1012455-12
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Failure to Deflate (4060)
Health Effect - Clinical Codes	Shock (2072); Vascular Dissection (3160); Embolism/Embolus (4438)
Date of Event	06/27/2024
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.B2: the date of death is estimated to be (b)(6) 2024 as this was the date of the procedure.
Event or Problem Description
It was reported that the patient presented with myocardial infarction (mi).After imaging, an impella device was inserted and 8 stents were implanted in the left main artery.The 5x12mm nc trek balloon dilatation catheter (bdc) was used for post dilatation of one of the non-abbott stents and the balloon inflated without issue; however, the balloon failed to deflate.After 15 minutes, the balloon was partially deflated to withdrawal the bdc from the left main artery.During removal the balloon separated from the delivery system in the aorta where an aortic dissection was suspected.The balloon then migrated to the groin where the balloon became stuck again; therefore, an attempt was made to perforate the balloon with a wire which was ultimately successful.The patient was stable and transferred to intensive care; however, the patient went into shock and subsequently died in intensive care.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.A medical review was conducted by an abbott vascular clinical specialist.This was a case of post-dilate stent that was placed in the left main (lm) artery of a patient having a myocardial infarction (mi) and a suspected aortic dissection.The etiology of the suspected aortic dissection was not reported.The intervention was protected with an impella catheter prior to the start of the intervention.Eight non-abbott stents were deployed in the lm.It is unknown how many inflations the 5.0 x 12 nc trek had been used for previously.The atmosphere pressure (atm) that the balloon was inflated to, was not reported.The length of time the balloon was held at negative prior to the removal attempt was not reported.The balloon remained inflated in the lm for 15 minutes before it partially deflated, and force was used to remove the partially inflated balloon from the lm.The force used caused the balloon catheter to separate and the distal portion to remain in the aorta.The balloon reportedly ¿migrated¿ to the groin, against the blood flow.It was not reported if the balloon catheter was snared or somehow pulled down to the groin in an attempt to remove the partially inflated balloon through the femoral artery.Due to the limited information provided, it cannot be definitively stated that the 5.0 x 12 nc trek caused or contributed to this patient¿s death without further information.Based on the reported information and results of the complaint investigation, there is no indication that the reported failure to deflate, balloon separation or entrapment of device are related to a potential product quality issue.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported separation, entrapment of device, unexpected medical intervention and hospitalization appear to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is likely that the reported failure to deflate contributed to the balloon separating during removal as additional force was likely required and subsequently the separated portion of the device remain in the patient anatomy.A conclusive cause for the reported patient effects of vascular dissection, embolism/embolus, shock and death and the relationship to the device, if any, cannot be determined.The reported patient effects of embolism/embolus, vascular dissection and death are listed in the coronary dilatation catheters (cdc), nc trek rx, global, 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
• 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: 19767559
• Report Number: 2024168-2024-08495
• Device Sequence Number: 21063020
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: (01)08717648152146(17)260731(10)30830G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 30830G1
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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: 4.5X22MM MEDTRONIC ONYX TRU STAR STENT; IMPELLA DEVICE
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown