MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Device Problems Difficult to Remove (1528); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems Angina (1710); Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199); Stenosis (2263)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Journal abstract: entrapment of balloon in bifurcation lesion pci with jailed balloon technique teppei noda kansai medical university, japan journal of the american college of cardiology, vol.71, no.16, suppl s, 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient presented with exertional angina.Angiogram showed chronic total occlusion in the rca, moderate stenosis in lm trunk and mid lad and severe stenosis and calcification in the 1st diagonal.Intravascular ultrasound (ivus) and 2.0 mm balloon failed to pass through 1st diagonal ostium.Predilatation to d1 with 1.5 mm balloon was performed.Ivus and 2.0 mm balloon with support catheter could not pass.Rotablation was performed.After rotablation, ivus and predilatation with 2.0 mm balloon was performed.Subsequently, lmt to proximal lad was dilated with 2.5 mm scoring balloon.Ivus showed residual stenosis at d1 ostium.To avoid d1 occlusion by main vessel stenting, a resolute-onyx stent was implanted from lmt to proximal lad with jailed balloon technique using 1.5/10 mm balloon.After stent implantation with low pressure, angiogram showed no occlusion of d1.An attempt to withdraw the jailed balloon, met with resistance.The jailed balloon got stuck outside the stent.Several attempts were made to draw the balloon with dilation and deflation many times and gradually, the balloon moved to stent mid portion.Then, the balloon was retrieved along with wire.This procedure caused stent deformation and proximal optimization technique with 3.5 mm balloon was done.Ivus showed well apposed stent and final angiogram showed good flow of main vessel and d1 without any complication.

Manufacturer Narrative

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

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7681627
• MDR Text Key: 114540626
• Report Number: 9612164-2018-01707
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• 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 Age: 76 YR