MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problems Chest Pain (1776); Vascular Dissection (3160)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Lit ref: doi.Org/10.1016/j.Ihjccr.2018.0812.If information is provided in the future, a supplemental report will be issued.

Event Description

Coronary angiography revealed occlusion of the proximal segment of the lad.During a pci procedure, a launcher guiding catheter and sprinter legend balloons were used.The left main (lm) was smoothly engaged with a 6f launcher.A non-medtronic guidewire was navigated across the occlusion to the distal lad and a 2.5x15 mm sprinter legend semi-compliant balloon was inflated at 12 atm to dilate the lesion.A non-medtronic stent was successfully deployed at 12 atm.Shortly after removal of the stent balloon, the patient experienced sudden onset chest pain, while remaining hemodynamically stable.Check cag revealed retrograde dissection from lad to lm and aorta.The lad wire was left in place and another wire was navigated into the left circumflex (lcx) artery.A non-medtronic stent was placed from the ostial lm towards proximal lad overlapping the previous stent.The stent was deployed at 10 atm followed by proximal optimization technique (pot) of the lm was done using non-complaint 4.5x9.0mm sprinter balloon at 10 atm.During this rescue procedure, the dissection started to appear in the ramus intermedius (ri) branch, which was navigated with non-medtronic wire and a 3.0x38 mm non-medtronic stent was deployed distally.It was followed by deployment of the stent at 12 atm in the proximal segment(with slight protrusion into the lm) overlapping the distal stent (t and protrusion technique).Final kissing balloon inflation was performed using a nc sprinter non-compliant 4.0x15 mm and 3.0x15 mm balloon in the lad and ri respectively.The patient developed no further adverse event during the remainder of the hospital stay and was discharged home in an overall good condition on third day.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8440469
• MDR Text Key: 139459388
• Report Number: 1220452-2019-00031
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K132673
• 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: 03/21/2019

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: 03/07/2019
• Initial Date FDA Received: 03/21/2019
• 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: 51 YR