SYNERGY¿

Report

Report Number: 2134265-2016-11582
Event Type: Death
Date Received: December 15, 2016
Date of Event: November 28, 2016
Report Date: November 28, 2016
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT WAS DAMAGED WITH STENT STRUTS BUNCHED AND OVERLAPPING ON PROXIMAL AND MID-SECTION, LESS DAMAGE ON THE DISTAL END OF THE STENT. DISTAL STENT STRUT ON ROW # 01 APPEARED TO BE SLIGHTLY EXPANDED. STENT DAMAGE MOST LIKELY OCCURRED DURING WITHDRAWAL ATTEMPTS. THE DISTAL EDGE OF THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BALLOON BODY WAS REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. BALLOON WINGS APPEARED NOT TO BE TIGHTLY FOLDED ON THE DISTAL END OF THE BALLOON. A VISUAL AND TACTILE EXAMINATION FOUND A HYPOTUBE BREAK 505MM FROM THE END OF DISTAL TIP, MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT WERE ALSO NOTED. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION FOUND INNER AND OUTER KINKS BETWEEN 5CM - 8CM PROXIMAL OF THE BI-COMPONENT BOND. THE BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID 2134265-2016-11576, 2134265-2016-11578, 2134265-2016-11579, 2134265-2016-11580, 2134265-2016-11581, 2134265-2016-11584. IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (LCX) ARTERY. DURING A DOUBLE BARRELED PERCUTANEOUS CORONARY INTERVENTION, TWO PT2 GUIDE WIRES WERE INSERTED INTO RESPECTIVE LESION. A 2.75 X 20MM SYNERGY¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LAD LESION. THE DEVICE WAS REMOVED AND ADDITIONAL DILATION WAS PERFORMED. THE 2.75 X 20MM SYNERGY¿ STENT WAS RE-ADVANCED BUT STILL FAILED TO CROSS THE LESION. DURING REMOVAL, IT WAS NOTED THAT THE PROXIMAL AND DISTAL EDGES OF THE STENT STRUTS WERE LIFTED. SUBSEQUENTLY, A 3.00 X 20 SYNERGY¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND PT2 GUIDE WIRE WAS ADVANCED INTO THE LCX LESION AND A MACH1 GUIDE CATHETER WAS ADVANCED. ADDITIONAL DILATATION WAS THEN PERFORMED USING A 2.50MM X 12MM NC EMERGE® BALLOON CATHETER. THE 3.00 X 20 SYNERGY¿ STENT WAS RE-ADVANCED HOWEVER, RESISTANCE AT THE TIP OF THE GUIDE CATHETER WAS ENCOUNTERED. THE STENT HUNG UP ON THE LESION AND SLIPPED OFF OF THE BALLOON. THE DISLODGED STENT MIGRATED TO THE OSTIUM OF THE CATHETER AND EMBOLIZED INTO THE CUSP AND ENDED UP IN THE DESCENDING AORTA. A USE OF SNARE WAS PLANNED TO RETRIEVE THE EMBOLIZED STENT. HOWEVER, THE PATIENT'S UNDERLYING CONDITION WORSENED AND THE PROCEDURE WAS ABORTED WITH CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT DIED ON THE TABLE.

Description of Event or Problem · 1

SAME CASE AS MDR ID 2134265-2016-11576, 2134265-2016-11578, 2134265-2016-11579, 2134265-2016-11580, 2134265-2016-11581, 2134265-2016-11584. IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (LCX) ARTERY. DURING A DOUBLE BARRELED PERCUTANEOUS CORONARY INTERVENTION, TWO PT2 GUIDE WIRES WERE INSERTED INTO RESPECTIVE LESION. A 2.75 X 20MM SYNERGY¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LAD LESION. THE DEVICE WAS REMOVED AND ADDITIONAL DILATION WAS PERFORMED. THE 2.75 X 20MM SYNERGY¿ STENT WAS RE-ADVANCED BUT STILL FAILED TO CROSS THE LESION. DURING REMOVAL, IT WAS NOTED THAT THE PROXIMAL AND DISTAL EDGES OF THE STENT STRUTS WERE LIFTED. SUBSEQUENTLY, A 3.00 X 20 SYNERGY¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND PT2 GUIDE WIRE WAS ADVANCED INTO THE LCX LESION AND A MACH1 GUIDE CATHETER WAS ADVANCED. ADDITIONAL DILATATION WAS THEN PERFORMED USING A 2.50MM X 12MM NC EMERGE® BALLOON CATHETER. THE 3.00 X 20 SYNERGY¿ STENT WAS RE-ADVANCED HOWEVER, RESISTANCE AT THE TIP OF THE GUIDE CATHETER WAS ENCOUNTERED. THE STENT HUNG UP ON THE LESION AND SLIPPED OFF OF THE BALLOON. THE DISLODGED STENT MIGRATED TO THE OSTIUM OF THE CATHETER AND EMBOLIZED INTO THE CUSP AND ENDED UP IN THE DESCENDING AORTA. A USE OF SNARE WAS PLANNED TO RETRIEVE THE EMBOLIZED STENT. HOWEVER, THE PATIENT'S UNDERLYING CONDITION WORSENED AND THE PROCEDURE WAS ABORTED WITH CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT DIED ON THE TABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
826042	SYNERGY¿	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493926220270	0019444376

Patients

Seq	Age	Sex	Outcome	Treatment
1	90 YR		Death	GUIDE WIRES: 185CM LIGHT SUPPORT STRAIGHT TIP PT²¿