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	H7493926028270
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is a combination product.(b)(4).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).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the circumflex artery.A 2.75 x 28 synergy ii drug-eluting stent was advanced to treat the lesion.However, the physician noticed that the stent looked funny under fluoroscopy.The device was removed from the patient's body and the stent struts were noted to be frayed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.:synergy ii us mr 2.75 x 28mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found severe damage.The proximal struts were pushed in a distal direction resulting in bunching of the mid section of the stent.Struts 1-8 from the distal end of the stent were undamaged and crimped in place.The crimped stent od(outer diameter) of the undamaged section was measured and was within max 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 tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of 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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the circumflex artery.A 2.75 x 28 synergy ii drug-eluting stent was advanced to treat the lesion.However, the physician noticed that the stent looked funny under fluoroscopy.The device was removed from the patient's body and the stent struts were noted to be frayed.No patient complications were reported.

• 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: 6585822
• Report Number: 2134265-2017-05303
• Device Sequence Number: 16282554
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: (01)08714729840282(17)20170830(10)19689822
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/11/2017

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: 08/30/2017
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Device Lot Number: 19689822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR