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	H7493926008300
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-02021.It was reported that stent damage occurred.The 80% stenosed target lesion was located in the calcified right coronary artery (rca).Following pre-dilation with 3.0x20mm and 3.5x15mm nc emerge balloon catheters, a 3.00 x 16mm synergy ii drug-eluting stent was advanced but would not cross the lesion.When the device was removed, it was noted that the stent was not on the balloon.X-ray was performed and it was confirmed that the stent stripped off the balloon in the rca, a guide wire was used to wrap around the stent.The stent, guide catheter and guide wire were removed as one unit.A 3.00 x 8mm synergy ii drug-eluting stent was advanced; however, it was noted that the stent struts got banged up and raised off of the balloon.Multiple additional inflations were then performed using a 3.0x20mm nc emerge balloon catheter and a guide extension catheter.The procedure was completed with another 3.00 x 8mm synergy stent.The patient did not experience any complications.
Event or Problem Description
Same case as mdr id: 2134265-2018-02021.It was reported that stent damage occurred.The 80% stenosed target lesion was located in the calcified right coronary artery (rca).Following pre-dilation with 3.0x20mm and 3.5x15mm nc emerge balloon catheters, a 3.00 x 16mm synergy ii drug-eluting stent was advanced but would not cross the lesion.When the device was removed, it was noted that the stent was not on the balloon.X-ray was performed and it was confirmed that the stent stripped off the balloon in the rca, a guide wire was used to wrap around the stent.The stent, guide catheter and guide wire were removed as one unit.A 3.00 x 8mm synergy ii drug-eluting stent was advanced; however, it was noted that the stent struts got banged up and raised off of the balloon.Multiple additional inflations were then performed using a 3.0x20mm nc emerge balloon catheter and a guide extension catheter.The procedure was completed with another 3.00 x 8mm synergy stent.The patient did not experience any complications.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage to proximal stent rows 1-2 with stent struts lifted and pulled in a distal direction.The undamaged crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.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.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and inner lumen and mid-shaft found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7347613
• Report Number: 2134265-2018-02020
• Device Sequence Number: 13649326
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2018
• Device Model Number: H7493926008300
• Device Catalogue Number: 39260-0830
• Device Lot Number: 0021126352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/17/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR