GLADIUS MONGO
Report
- Report Number
- 3003775027-2024-00035
- Event Type
- Death
- Date Received
- March 22, 2024
- Report Date
- March 22, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- PMA / PMN Number
- K180784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE DISCARDED AND NOT RETURNED FROM THE USER FACILITY. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. DUE TO LIMITED WRITTEN INFORMATION ON THE ARTICLE WHICH DEVICES HAD BEEN USED FOR WHICH PATIENTS AND WHAT CAUSED THE REPORTED MACCES, IT WAS UNABLE TO DETERMINE WHETHER OR HOW GLADIUS MONGO GUIDE WIRES HAD CAUSED OR CONTRIBUTED TO THE EVENTS. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENTS ANATOMY AND/OR PROCEDURAL CONTENTS WERE LIKELY ASSOCIATED WITH THE EVENTS. IT WAS CONCLUDED THAT THE REPORTED EVENTS WERE NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ~ USE THIS GUIDE WIRE CAREFULLY AS THE GUIDE WIRE MAY PENETRATE THE BLOOD VESSEL. OTHERWISE, IT MAY CAUSE ADVERSE EVENTS SUCH AS BLOOD VESSEL PERFORATION AND CORONARY ARTERY DISSECTION. THE HIGHER TORQUE PERFORMANCE, STIFFER DISTAL END, AND/OR HIGHER ADVANCEMENT FORCE MAY PRESENT A HIGHER RISK OF PERFORATION OR INJURY THAN IF USING A MORE FLEXIBLE GUIDE WIRE. THEREFORE, USE THE MOST FLEXIBLE GUIDE WIRE THAT WILL TREAT THE LESION (I.E., THE GUIDE WIRE WITH THE SMALLEST TIP LOAD THAT WILL TREAT THE LESION), AND TAKE DUE CARE TO MINIMIZE THE RISK OF PERFORATION OR OTHER DAMAGE TO BLOOD VESSELS. [MALFUNCTION AND ADVERSE EFFECTS]. ~ DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION. ~ VESSEL DISSECTION. ~ CARDIAC TAMPONADE DUE TO VESSEL PERFORATION.
IT WAS REPORTED THROUGH LITERATURE THAT AN ASAHI GLADIUS MONGO GUIDE WIRE MIGHT HAVE CAUSED OR CONTRIBUTED TO MAJOR ADVERSE CARDIAC OR CEREBROVASCULAR EVENTS (MACCES). PUBLICATION: CATHETER CARDIOVASC INTERV. 2023;102:864-877. TITLE: WIRE-BASED ANTEGRADE DISSECTION RE-ENTRY TECHNIQUE FOR CORONARY CHRONIC TOTAL OCCLUSIONS PERCUTANEOUS REVASCULARIZATION: EXPERIENCE FROM THE ERCTO REGISTRY EXCERPTS: EXCERPTS ARE AS FOLLOWS: [METHODS] IN THIS STUDY, TECHNICAL SUCCESS, PROCEDURAL SUCCESS, AND LONG-TERM OUTCOME OF ANTEGRADE WIRING AND REENTRY (ADR) TECHNIQUES IN COMPARISON TO ANTEGRADE WIRING (AW). THE PATIENTS INCLUDED IN THIS STUDY WERE THOSE WHO HAD BEEN ENROLLED IN THE EUROPEAN REGISTRY OF CTOS (ERCTO) REGISTRY BETWEEN JANUARY 2018 AND DECEMBER 2021, AT 13 CENTERS WHERE ADR IS WIDELY PERFORMED (CUT-OFF TO BE INCLUDE), AND THOSE WHO UNDERWENT ANTEGRADE CTO PCI. UNSUCCESSFUL RETROGRADE PROCEDURES, FOLLOWED BY THE ANTEGRADE APPROACH WERE INCLUDED AS WELL. ON THE OTHER HAND, SUCCESSFUL RETROGRADE PROCEDURES, DEVICE-BASED ADR PROCEDURES, AND PATIENTS WITH MISSING DATA HAVE BEEN EXCLUDED. THE PRIMARY ENDPOINT AT FOLLOW-UP WAS THE MACCE RATE. MACCES INCLUDED CARDIAC DEATH, MI, STROKE, RECURRENT SYMPTOMS REQUIRING REPEAT TARGET VESSEL REVASCULARIZATION (TVR) WITH EITHER PCI OR CORONARY ARTERY BYPASS GRAFTING. WIRE-BASED ADR TECHNIQUES WERE PERFORMED EITHER AS A FIRST-LINE APPROACH OR AS A BAILOUT PROCEDURE AFTER THE FAILURE OF ANTEROGRADE OR RETROGRADE STRATEGY. THE WIRE-BASED ADR TECHNIQUE WAS PERFORMED AMONG OPERATORS BY DIFFERENT WIRES: SOFT POLYMERIC WIRES SUCH AS FIELDER FC, XT, AND XTR (ASAHI INTECC) ACCORDING TO THE MINI SUBINTIMAL TRACKING AND REENTRY (MINI-STAR) TECHNIQUE; INTERMEDIATE/MODERATE/STIFF POLYMERIC WIRES SUCH AS PILOT 50, 150, AND 200 (ABBOTT); THE NEW STIFF POLYMERIC WIRE MONGO (GLADIUS MG 14) AND GLADIUS (GLADIUS 14) (ASAHI INTECC), OR STIFF HYDROPHILIC WIRES FOLLOWED BY POLYMERIC WIRES AND VICE VERSA TO RE-ENTER ACCORDING TO THE LIMITED ANTEGRADE SUBINTIMAL TRACKING (LAST) TECHNIQUE. [RESULTS] FROM JANUARY 2018 TO DECEMBER 2021, 3136 PATIENTS WITH CTO LESIONS UNDERWENT 3345 CTO PROCEDURES. THE FINAL STUDY POPULATION CONSISTED OF 1710 PATIENTS, CORRESPONDING TO 1806 LESIONS, TREATED BY AN ANTEGRADE APPROACH. AMONG THE 1806 LESIONS, 1309 (72%) WERE PERFORMED BY AW TECHNIQUES AND 497 LESIONS (28%) BY WIRE-BASED ADR TECHNIQUES. AMONG WIRE-BASED ADR PROCEDURES, MINI-STAR, STAR, LAST, AND ANTEGRADE FENESTRATION AND RE-ENTRY TECHNIQUE (AFR) WERE USED IN 62, 28, 8, AND 2 OF THE CASES. THE OVERALL TECHNICAL SUCCESS RATE WAS 94.7%; AS COMPARED WITH AW, WIRE-BASED ADR SHOWED A LOWER TECHNICAL SUCCESS RATE (90.3% VS. 96.4%; P < 0.001). MAJOR COMPLICATIONS WERE SIMILAR IN THE WIRE-BASED ADR GROUP THAN IN THE AW GROUP. AMONG ALL THE OTHER PROCEDURAL-RELATED COMPLICATIONS, ONLY CONTRASTINDUCED NEPHROPATHY OCCURRED MORE OFTEN IN THE WIRE-BASED ADR GROUP THAN IN THE AW GROUP (5.2% VS. 2.6%, P = 0.008) [TABLE 3] - PROCEDURAL CHARACTERISTICS AND COMPLICATIONS. (CTO LESIONS: N=1806, AW: N=1309, ADR: N=497) <MAJOR COMPLICATIONS> DEATH --- CTO LESIONS: 2 (0.1%), AW: 1 (0.1%), ADR: 1 (0.2%), P=0.41 Q-WAVE MI --- CTO LESIONS: 3 (0.1%), AW: 1 (0.1%), ADR: 2 (0.4%), P=0.382 NON-Q-WAVE MI --- CTO LESIONS: 14 (0.7%), AW: 7 (0.5%), ADR: 7 (1.4%), P=0.111 CLINICALLY DRIVEN TLR --- CTO LESIONS: 6 (0.3%), AW: 3 (0.2%), ADR: 3 (0.6%), P=0.437 PERFORATION WITH TAMPONADE --- CTO LESIONS: 16 (0.8%), AW: 10 (0.7%), ADR: 6 (1.2%), P=0.537 STROKE --- CTO LESIONS: 3 (0.1%), AW: 3 (0.2%), ADR: 0%, P=NS <OTHER COMPLICATIONS> MINOR PERFORATIONS --- CTO LESIONS: 33 (0.1%), AW: 19 (1.5%), ADR: 14 (2.8%), P=0.082 CONTRAST-INDUCED NEPHROPATHY --- CTO LESIONS: 60 (3.3%), AW: 34 (2.6%), ADR: 26 (5.2%), P=0.008 DISSECTION OF DONOR ARTERY --- CTO LESIONS: 9 (0.4%), AW: 3 (0.2%), ADR: 4 (0.8%), P=0.182 VASCULAR COMPLICATIONS --- CTO LESIONS: 3 (0.1%), AW: 0 (0%), ADR: 3 (0.6%), P=NS FIELDER FC: MFR REPORT #3003775027-2024-00032 FIELDER XT: MFR REPORT #3003775027-2024-00033 FIELDER XT-R: MFR REPORT #3003775027-2024-00034 GLADIUS: MFR REPORT #3003775027-2024-00036
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2554086 | GLADIUS MONGO | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening| D| O |