MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problem Vascular Dissection (3160)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and calcified lesion located in the mid lad.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.No difficulties were noted when removing the protective sheath.The lesion was pre-dilated.The inflation device remained on neutral pressure during delivery of the device.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It is reported that a dissection of the artery had occurred prior to attempting to cross the lesion with the resolute onyx, and an attempt was made get the stent across it after getting a balloon to cross.The lesion was ballooned twice, so that the stent could be delivered.The resolute onyx did not cause the dissection.It was assessed that either the non-medtronic wire or the euphora balloon caused the dissection.It was reported that while attempting to use a buddy wire to deliver the stent through the lesion that stent dislodgement occurred.An attempt was made to remove the dislodged stent using a balloon, however the balloon became stuck in the stent and in the guide.The dislodged stent was unable to be removed from the patient.The patient was transferred to another hospital for emergency bypass surgery.The stent was removed during surgery.No patient injury has been reported post procedure.The patient left the hospital after successful surgery.The original euphora balloon used to dilate was not the same as the balloon they used after the dislodgement to try and remove the stent.

Manufacturer Narrative

Add info: the lesion was pre-dilated using a euphora balloon catheter.A last chance effort was made to remove the dislodged stent using a different 1.5mm euphora balloon.Using the balloon was not the cause of the dislodgement.This 1.5mm euphora was removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: one image and one video were provided for analysis.In the still image, a guide catheter is positioned in vivo with an unidentified device loaded into the guide catheter.No other relevant details are visible in the image.A video was provided.The video is of very poor quality and details on the moving images cannot be clearly seen.It is possible to see contrast being administered to the left coronary system but no other details from the reported event are visible in the video due to the image blur.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8280724
• MDR Text Key: 134178066
• Report Number: 9612164-2019-00329
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 03/05/2019
• Supplement Dates FDA Received: 02/19/2019; 03/08/2019
• 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
• Patient Age: 71 YR