FDA Adverse Event Injury Summary report: N

SYNERGY¿ XD

MDR report key: 17930229 · Received October 13, 2023

Report

Report Number
17930229
Event Type
Injury
Date Received
October 13, 2023
Date of Event
July 31, 2023
Report Date
September 13, 2023
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NIQ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

PERFORMED CARDIAC CATH WITH INTERVENTION PTCA PERFORMED WITH 2.0X12 EMERGE, THEN ATTEMPTED TO CROSS LESION WITH 2.25 X 12 SYNERGY, UNABLE TO CROSS LESION, STENT REMOVED. ATTEMPTED TO CROSS WITH 3.5X12 SHOCK WAVE BALLOON, UNABLE TO CROSS, REMOVED. 3.0X12 EMERGE CROSSED LESION AND BALLOON WAS INFLATED X 2, EMERGE REMOVED. 3.5X12 SHOCKWAVE AGAIN ATTEMPTED TO CROSS LESION, UNABLE TO CROSS, REMOVED. 3.5X15 NC QUANTUM ADVANCED AND ABLE TO CROSS INFLATED X 1, NC QUANTUM REMOVED AGAIN ATTEMPTED TO ADVANCE 3.5X12 SHOCK WAVE, UNABLE TO CROSS, ATTEMPTED USING GUIDELINER AND ONCE AGAIN ADVANCING SHOCKWAVE UNABLE TO CROSS, GUIDELINER REMOVED. ROTA WIRE EXTRA SUPPORT ADVANCED, ATTEMPTED TO ADVANCE 1.5 BUR UNABLE TO ADVANCE AND LOST WIRE AND GUIDE SUPPORT. BURR AND ROTAWIRE REMOVED. ONCE WIRE ADVANCE ATTEMPTED 2.5X12 SHOCKWAVE ABLE TO CROSS, 3 SETS OF 10 IMPULSES DELIVERED, FOLLOWED BY AN ADDITIONAL SET OF 10 IMPLULSES. SHOCKWAVE REMOVED. 3.5X15 NC ADVANCED AND ONE INFLATION PERFORMED. NC REMOVED 2.5X12 SHOCKWAVE ATTEMPTED TO BE ADVANCED, UNABLE TO CROSS, 3.5X12 SHOCKWAVE ATTEMPTED TO BE ADVANCED, UNABLE TO CROSS, 2.0X6 WOLVERINE ADVANCED, UNABLE TO CROSS. WIRE CHANGED OUT, ATTEMPTED TO ADVANCE 2.5X 12 SHOCKWAVE UNABLE TO CROSS, GUIDEWIRE CHANGED, ATTEMPTED TO ADVANCE 3.5X12 SHOCKWAVE UNABLE TO ADVANCE. EVERYTHING REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1552419 SYNERGY¿ XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION H7493941812220

Patients

Seq Age Sex Outcome Treatment
1 24455 DA Female Required Intervention| L