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 Patient Problem/Medical Problem (2688)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

A presentation showing still images of the vessel prior treatment of the cto of the rca and post treatment were provided.Timi iii was re-established in the rca post ballooning of the cto.This pre-dilatation of the distal lesion appears to have resulted in an int imal dissection/perforation of the vessel at the site of ballooning.This is not an unusual outcome for a diseased vessel.It appears most likely that multiple balloon inflations to pressurise the calcified or fibrotic lesion site resulted in the occurrence of the confirmed vessel perforation.There is no confirmed evidence to suggest that product sizing caused the perforation.

Event Description

It was reported that the patient suffered in-stent restenosis within a previously implanted non mdt stent and also chronic total occlusion in a separate lesion.From previous stent implantation, the physician knew that the lesion size was 2.50mm or greater and therefore decided that the chronic total occlusion lesion located distal to the instent restenosis lesion would be treated using a resolute integrity 2.25*26mm drug eluting stent.No damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues found.The lesion was pre-dilated using 4 balloons (euphora 2.75 x 20mm inflated once and euphora 2.0 x 30mm inflated 3 times).Two other n on-mdt balloons were also used.During the procedure, the stent deliver system (sds) did pass through a previously-deployed stent, resistance was not encountered when advancing the device and no excessive force was used during delivery.The lesion was located in the rca with no tortuosity and no calcification.It was reported that after pre-dilation a perforation was observed but this was expected as the lesion was very diseased.The physician deemed no adverse event occurred due to use of the euphora balloons.The resolute integrity stent was implanted however it was observed the stent was bigger than expected.It was reported that this was observed at 10 atm and it was noted that the inflation device was inflated slowly.The resolute integrity was still implanted.The perforation was treated by implantation of a non-mdt stent to achieve hemostasis.It was reported that the physician suspects that the resolute integrity was 2.75mm instead of 2.25mm- bigger than expected.

• 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: 6743242
• MDR Text Key: 80987309
• Report Number: 9612164-2017-00942
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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
• Date Manufacturer Received: 06/27/2017
• 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: 61 YR
• Patient Weight: 55