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	H7493926032220
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 32 synergy ii stent was selected for use.However, during preparation, upon removing the stent protector, the stent was also removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 32mm was returned for analysis.The stent delivery system was not returned for analysis.Only the stent was returned; the sds was not returned for analysis.The entire length of the stent was damaged.The sds containing the specific catheter batch number was not returned so it was not possible to carry out a review of the manufacturing data for this specific device.The product stent protector was not returned for analysis with the device, however the specified inside diameter of the stent protector was measured.As the stent was damaged the crimped stent profile could not be measured however, 100% in process inspection was carried out and any defective unit identified is scrapped accordingly from the catheter batch.Therefore this device would have been scrapped if the maximum crimped stent profile measurement was outside specification.No other issues were identified during the product analysis.The specific batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 32 synergy ii stent was selected for use.However, during preparation, upon removing the stent protector, the stent was also removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: 6521083
• Report Number: 2134265-2017-04400
• Device Sequence Number: 788889
• Product Code: NIQ
• UDI-Device Identifier: 08714729840329
• UDI-Public: (01)08714729840329(17)20170707(10)19471962
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/18/2017

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: 07/07/2017
• Device Model Number: H7493926032220
• Device Catalogue Number: 39260-3222
• Device Lot Number: 19471962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1