MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER

Catalog Number 1012270-15

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

Patient Problems Intimal Dissection (1333); Occlusion (1984); Perforation (2001)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Patient (b)(6).The post procedure rca stenosis had 0% residual stenosis and a timi flow of iii.A 2.75 x 12 rx vision bms was then deployed in an unspecified non-rca vessel with a maximum pressure of 12 atm.A 014 balance middleweight 300 cm guide wire was then advanced to this distal target vessel.A 3.5 x 12 nc trek balloon was advanced but was also unable to cross.A 3.5 x 12 trek nc bdc crossed and was inflated to a maximum pressure of 12 atm.A 2.5 x 12 mini vision bms was deployed in an unspecified non-rca vessel at 10 atm.A 2.5 x 15 vision bms was advanced but failed to cross.A 4.0 x 12 trek nc balloon was advanced but also failed to cross.None of the failure to cross devices caused or contributed to any adverse patient effects or any clinically significant delay.An unspecified rx balloon catheter crossed and completed final dilatation in an unspecified non-rca vessel.While the spiral dissection was resolved and the patient remained stable, the patient was transferred to another facility to undergo cabg for repair / replacement of the ascending aorta.No additional information was provided.Concomitant medical products: guide wire: volcano pressure wire; 014 hi-torque (ht) floppy ii 190 cm (x2).Inflation: copilot inflation kit, guide cath: 6fr jr4 cordis, sheath: 6fr x 7 cm merit medical.The device was not returned.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during the procedure to treat a 100% stenosed right coronary artery (rca) with a timi flow of 0, a 6fr x 7 cm non-abbott access sheath was inserted via right radial artery access, followed by advancement of a 6fr jr4 non-abbott guiding catheter, a non-abbott pressure wire, and two 014 hi-torque (ht) floppy ii 190 cm wires to the distal rca.Pre-dilatation was performed using a 2.0 x 15 mm mini trek rx balloon dilatation catheter (bdc) inflated with a copilot inflation kit.A coronary spiral dissection of the ostial proximal right coronary artery (rca) with complete occlusion and perforation with contrast extravasation of the distal rca area into the aortic wall was observed.While an emergent coronary artery bypass graft (cabg) surgery was needed, there were no available facilities to treat the patient with cabg.Thus, a 3.5 x 16 mm rx graftmaster covered stent was deployed at 15 atmospheres (atm) for 20 seconds ostial proximal rca, resolving the spiral dissection and improving flow down the rca and posterior descending (pd) coronary artery.The uncovered distal rca staining was stable and the patient remained hemodynamically stable.For additional repair to the independent vessel area distal to the deployed graftmaster, the procedure was continued as follows: a 2.75 x 23 rx vision bare metal stent (bms) was then deployed at 10 atm.Another 2.75 x 23 rx vision bms was advanced but failed to cross.Dilatation was performed with a 3.0 x 15 trek rx balloon.A 2.5 x 18 rx mini vision bms was then deployed at 12 atm, followed by deployment of a 3.5 x 12 rx vision bms at 10 atm.A 2.75 x 18 rx vision and 2.75 x 12 rx vision bms were each advanced but failed to cross.*.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of dissection, occlusion and perforation are listed in the mini trek rx ifu, as known patient effects.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6476395
• MDR Text Key: 72250308
• Report Number: 2024168-2017-02968
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012270-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 80