MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926016350

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that balloon removal difficulty, shaft break, stent damage and stent explantation occurred.The target lesion was located in the proximal left anterior descending artery (lad).After a 3.50x 6 synergy ii everolimus-eluting platinum chromium coronary stent system was deployed, removal of the stent delivery system (sds) was attempted.However, the sds balloon became stuck on the stent and would not come back.A great force was applied to remove the device, but the shaft was separated and broke in half.The physician was able to grab the shaft with a lot of force and removed the device from the patient, but the stent was explanted and still on the balloon and deformed.The procedure was completed using a new guide, a non-bsc guide extension catheter and a 3.5x22mm non-bsc stent.No patient complications were reported and the patient¿s status was fine.

Manufacturer Narrative

Device evaluated by mfr: synergy ii, us, mr, 3.5 x 16mm stent delivery system (sds) was returned.A visual examination found the stent to be severely damaged.Struts overlapping and bunched towards the distal end of the balloon.The balloon showed signs that positive pressure was applied.Crimp pillowing/markings were not evident on the entire length of the balloon - highly pronounced crimp pillowing/markings would suggest that the balloon did not receive any significant positive pressure.A visual and tactile examination found several hypotube kinks along full length of catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found a break in the polymer extrusion proximal of the port exchange site.The port bond also showed sign of a neck down.The bi-component bond showed no signs of damage or strain.A visual examination found no tip damage.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).

Event Description

It was reported that balloon removal difficulty, shaft break, stent damage and stent explantation occurred.The target lesion was located in the proximal left anterior descending artery (lad).After a 3.50x 6 synergy ii everolimus-eluting platinum chromium coronary stent system was deployed, removal of the stent delivery system (sds) was attempted.However, the sds balloon became stuck on the stent and would not come back.A great force was applied to remove the device, but the shaft was separated and broke in half.The physician was able to grab the shaft with a lot of force and removed the device from the patient, but the stent was explanted and still on the balloon and deformed.The procedure was completed using a new guide, a non-bsc guide extension catheter and a 3.5x22mm non-bsc stent.No patient complications were reported and the patient¿s status was fine.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6187001
• MDR Text Key: 62758042
• Report Number: 2134265-2016-11592
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: (01)08714729840121(17)20170407(10)19134491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2017
• Device Model Number: H7493926016350
• Device Catalogue Number: 39260-1635
• Device Lot Number: 19134491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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 Outcome(s): Other