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	H7493926016220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.  device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the stent found that the stent was returned expanded on the balloon and damaged.The stent was not crimped to the balloon and could be moved.The stent was removed from the balloon and placed in a beaker.The crimped stent outer diameter at the time of manufacture was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip found 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 section found no issues along the shaft polymer extrusion.An attempt was made to load the device on a 0.014¿¿ guidewire however this failed due to hardened medium present in the wire and inflation lumen.The sds was soaked in water bath at 37 degrees celsius in an attempt to remove the hardened medium.After soaking overnight, the device was loaded on a 0.014¿¿ guidewire without issue.A red substance resembling blood came from the wire lumen.The balloon folds appeared relaxed from there originally folded position.Stent crimp markings were present on the balloon body.The balloon was inflated to rated burst pressure without issue and a vacuum was pulled.The device deflated fully within deflation time specification.The encore inflation device was verified before and after use.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 was unable to be determined.(b)(4).
Event or Problem Description
A 2.25 x 16mm synergy ii drug-eluting stent was received with no issues reported.However, upon review of this device, stent damage occurred.

• 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: 7728382
• Report Number: 2134265-2018-06683
• Device Sequence Number: 16314670
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2018

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: 02/15/2019
• Device Model Number: H7493926016220
• Device Catalogue Number: 39260-1622
• Device Lot Number: 21763024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1