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 H7493926016400

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(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 medwatch will be filed.(b)(4).

Event Description

It was reported that removal difficulties and balloon detachment occurred.The target lesion was located in the heavily calcified left anterior descending artery.A 4.00 x 16mm synergy ii drug-eluting stent was advanced over a non bsc guidewire and through a non bsc guide catheter.The synergy ii stent was successfully implanted, removal difficulties were encountered during the removal of the stent delivery balloon.The stent delivery system, guidewire and guide catheter were removed together.It was noted that the balloon came apart on the guide wire.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: synergy ii us mr 4.00 x 16mm stent delivery system was returned for analysis.The device was returned with a 0.070'' guide catheter.No visible damage to guide catheter.The distal portion of the device was returned on a 0.014¿ guide wire.The stent was not returned as it was deployed in the procedure.The balloon body was reviewed and it was noted that the distal portion of the balloon was bunched.This most likely occurred when an attempt was made to pull the partially deflated balloon back into the guide catheter.There was hardened medium resembling blood inside the guide catheter.Due to the condition of the returned device, functional testing of the balloon was not possible.A visual and tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion revealed a break at wire exchange port 1160 mm from the distal end of the strain relief.The inner shaft polymer extrusion was bunched 1.5mm distal from the bi-component bond.The distal portion of the device returned on a 0.014'' guide wire.It was not possible to remove the guide wire due to polymer extrusion damage.The tip was visually and microscopically examined and no issues were noted.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that removal difficulties and balloon detachment occurred.The target lesion was located in the heavily calcified left anterior descending artery.A 4.00 x 16mm synergy ii drug-eluting stent was advanced over a non bsc guidewire and through a non bsc guide catheter.The synergy ii stent was successfully implanted, removal difficulties were encountered during the removal of the stent delivery balloon.The stent delivery system, guidewire and guide catheter were removed together.It was noted that the balloon came apart on the guide wire.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
• MDR Report Key: 7362398
• MDR Text Key: 103412317
• Report Number: 2134265-2018-02004
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Model Number: H7493926016400
• Device Catalogue Number: 39260-1640
• Device Lot Number: 21426226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: BMW WIRE; GUIDE: MEDTRONIC Z2 EBU 3.5SH