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

Model Number 1012272-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The graftmaster devices referenced are being filed under separate medwatch report numbers.

Event Description

On (b)(6) 2019, the patient presented with a right coronary artery (rca) chronic total occlusion, left main, left circumflex, and left anterior descending (lad) coronary artery disease.The lad had an ulcerated proximal plaque, was extremely stenotic, and thrombotic occlusion was observed.Balloon dilatation was performed using a trek rx without noted issues and antiplatelet medication provided.Aspiration thrombectomy was performed and medications provided.Two non-abbott stents (onyx) were implanted in the proximal lad.Balloon dilatation was then performed using a 2.5x15mm trek rx catheter when a mid-distal lad dissection occurred.As treatment, additional angioplasty and a non-abbott stent (onyx) was implanted.Medications were also provided.Timi flow i was observed and additional balloon dilatation was performed using a non-abbott dilatation catheter (euphora) when a distal lad perforation occurred.Medications were provided.Three graftmaster stent delivery systems (2.8x26mm, then a 2.8x16mm, and another 2.8x26mm) were unable to cross the previously implanted, non-abbott stents to the treatment site.During this procedure, the patient experienced chest pain, became combative, was intubated, and anesthesia provided.The patient had coded (cardiopulmonary arrest).Additional dilatation was performed using multiple balloon catheters.An intra-aorta balloon pump was placed, continuous cardiopulmonary resuscitation was performed, and medications administered.Additional aspiration thrombectomy was performed.Timi flow ii was observed, and the patients condition declined.Once off the iabp, there was no underlying heart rhythm and no blood pressure.The patient had expired that day.No additional information was provided regarding this issue.

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.The reported patient effect of dissection is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9572246
• MDR Text Key: 178346969
• Report Number: 2024168-2020-00535
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: 08717648138294
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 90820G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS 6F; TWO ONYX STENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77