SYNERGY¿
Report
- Report Number
- 2134265-2016-10751
- Event Type
- Malfunction
- Date Received
- November 28, 2016
- Date of Event
- November 6, 2016
- Report Date
- November 7, 2016
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- SIMILAR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).
DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET EQUIDISTANT BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE UNDAMAGED PROXIMAL STENT OD (OUTER DIAMETER) WAS MEASURED AND IS WITHIN MAXIMUM CRIMPED STENT SPECIFICATION. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. BASED ON THE EVENT DESCRIPTION, THE BALLOON RUPTURED, HOWEVER NO EVIDENCE OF DAMAGE WAS OBSERVED ON THE BALLOON. THE DELIVERY CATHETER WAS CONNECTED TO AN ENCORE INFLATION DEVICE AND AN ATTEMPT WAS MADE TO APPLY POSITIVE PRESSURE TO THE BALLOON CHAMBER; HOWEVER THE DEVICE LEAKED AT THE PORT WELD SITE. THE BUMPER TIP OF THE DEVICE SHOWED SLIGHT SIGNS OF DAMAGE TO THE DISTAL EDGE OF THE TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH RESISTANCE BEING ENCOUNTERED ON ADVANCEMENT OF THE STENT DELIVERY CATHETER TO THE LESION SITE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE SEVERE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION OF THE MIDSHAFT FOUND DAMAGE AT THE PORT BOND EXIT SITE. THE HYPOTUBE TAB AT THE BACK OF THE PORT WAS NOTED TO BE INCORRECTLY SEATED DUE TO THE MIDSHAFT BEING TWISTED AT THE PORT SITE. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE DURING EXAMINATION; HOWEVER THE INFLATION FLUID LEAKED THROUGH THE PORT BOND SITE, THUS CONFIRMING THE DAMAGE CONCENTRATED AT THIS LOCATION AND MOST LIKELY OCCURRED DURING PROCEDURE. THE INNER LUMEN, OUTER EXTRUSION AND BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. 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 ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 20 SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS POSITIONED AND INITIAL INFLATION OF THE BALLOON WAS ATTEMPTED, THE BALLOON WAS HARD TO INFLATE. THE DEVICE WAS COMPLETELY REMOVED AND THE BALLOON WAS THEN FOUND TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 20 SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS POSITIONED AND INITIAL INFLATION OF THE BALLOON WAS ATTEMPTED, THE BALLOON WAS HARD TO INFLATE. THE DEVICE WAS COMPLETELY REMOVED AND THE BALLOON WAS THEN FOUND TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779544 | SYNERGY¿ | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493926220250 | 18879802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |