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	H7493926024220
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(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 stent damage occurred.The target lesion was located in the left anterior descending (lad) artery.A 2.25 x 24 synergy ii drug-eluting stent was advanced to treat the lesion.However, the proximal edge of the stent was crumpled about 5mm distal to the proximal radiopaque marker.The device was pulled out and the procedure was completed with implantation of two different synergy stents.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device lot number corrected from 20192166 to 0019299729.Device expiration date corrected from 01/19/2018 to 05/17/2017.Device manufactured date corrected from 01/31/2017 to 06/13/2016.(b)(4).Synergy ii us mr 2.25 x 24mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage and distal movement on the balloon.Stent was severely damaged and bunched at the center.Proximal end of stent had moved distally on the balloon such that the proximal end of the stent was 8mm distal from the distal edge of the proximal marker band.The distal end of the stent had moved slightly distally on the balloon.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.Crimp markings evident on exposed proximal balloon wall, indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found no issues.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 left anterior descending (lad) artery.A 2.25 x 24 synergy ii drug-eluting stent was advanced to treat the lesion.However, the proximal edge of the stent was crumpled about 5mm distal to the proximal radiopaque marker.The device was pulled out and the procedure was completed with implantation of two different synergy stents.No patient complications were reported and the patient's status was fine.

• 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: 6534062
• Report Number: 2134265-2017-04190
• Device Sequence Number: 1266886
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: (01)08714729840206(17)20180119(10)20192166
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/11/2017

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: 05/17/2017
• Device Model Number: H7493926024220
• Device Catalogue Number: 39260-2422
• Device Lot Number: 0019299729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1