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

Catalog Number 1012276-15

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

Patient Problem Intimal Dissection (1333)

Event Date 04/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effect of intimal dissection is listed in the coronary dilatation catheters, trek rx global, instructions for use as a known patient effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.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 and the treatment appears to be related to operational circumstances.

Event Description

It was reported that the procedure was to treat a lesion located in the heavily calcified right coronary artery (rca).The patient presented experiencing a st elevation myocardial infarction.Pre-dilatation was performed on the lesion with a 3.0 x 12 mm trek balloon catheter.Despite pre-dilatation being performed the implant delivery system could not be advanced into the target lesion.The delivery system was retracted from the anatomy without issue and a 3.5 x 15 mm trek was advanced for additional pre-dilatation and inflated three times (2 times at 18 atmospheres (atm) and 1 time at 20 atm.) during pre-dilatation a dissection was observed.The dissection was treated at the same time as the lesion with three xience prox stents with a good result; however, after deployment a small dissection confirmed to be caused by the trek balloon, was observed in one of the small side branches of the rca which was not treated.On 4/13/2016 the side branch was reassessed and was fine; therefore, no treatment was performed.The patient is reported to be well.No additional information was provided.

• Brand Name: 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 5598749
• MDR Text Key: 43349329
• Report Number: 2024168-2016-02581
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1012276-15
• Device Lot Number: 60104G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Required Intervention