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	H7493926024350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.50x24mm synergy ii everolimus-eluting platinum chromium coronary stent system was advanced through a 6f diagnostic catheter, however, the shaft broke.The physician attempted to use a non-bsc stent but device was unable to advance.The procedure was not completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Describe event or problem, device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached; method codes, result codes and conclusion codes.(b)(4).
Event or Problem Description
It was further reported that the device was completely removed from the patient's body by pulling it off from the wire.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.There was no stent on the sds.The balloon body was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were evident on the entire length of the balloon wall which verifies that the stent was crimped on the balloon prior to shipping.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.A break in the hypotube shaft at approximately 480mm distal from the distal end of the strain relief was also noted during analysis.A visual and tactile examination of the outer and mid-shaft section found that the inner shaft polymer extrusion was bunched at approximately 35mm proximal to the distal end of the proximal markerband.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 further reported that the device was completely removed from the patient's body by pulling it off from the wire.

• 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: 6506717
• Report Number: 2134265-2017-03996
• Device Sequence Number: 1641404
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: (01)08714729840244(17)20180206(10)20291050
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 04/06/2017

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: 02/06/2018
• Device Model Number: H7493926024350
• Device Catalogue Number: 39260-2435
• Device Lot Number: 20291050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/12/2017; 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR