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

Catalog Number 1012274-12

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Stroke/CVA (1770)

Event Date 11/25/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical devices: guide wire: transcend. Sheath: 6 fr flexor. (b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

Event Description

The index procedure date was (b)(6) 2014. The procedure was to treat a severe stenosis of the distal right internal carotid artery. A non-abbott guide wire was advanced toward the target lesion. The lesion was predilated using a 3. 0x12mm trek rx balloon dilatation catheter (bdc). The device was removed and a 3. 0x12mm non-abbott stent delivery system (sds) was advanced toward the target lesion in an attempt to cross the side of the lesion for deployment but failed. The device was removed and a 3. 0x9mm non-abbott sds was advanced toward the target lesion in an attempt to cross the side of the lesion for deployment and again failed. The 3. 0x9mm non-abbott stent dislodged from the balloon and all attempts to retrieve the stent were unsuccessful. A dissection was noted in the right internal carotid artery and partial closure of the internal carotid artery. The procedure was ended and all interventional equipment was removed. Reportedly during the procedure the patient suffered a stroke. No additional information was provided.

Manufacturer Narrative

(b)(4). The device was not returned for evaluation. 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. Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. It should be noted that the coronary dilatation catheters (cdc), trek rx instruction for use states: the trek rx coronary dilatation catheters is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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): 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: 6191413
• MDR Text Key: 62908472
• Report Number: 2024168-2016-09059
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1012274-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/17/2017
• 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 Treatment Data

Date Received: 12/20/2016 Patient Sequence Number: 1