MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10606
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date as there was no date provided.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x32mm synergy drug-eluting stent was selected for use.However, it was noted that a piece broke in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.B3 date of event corrected from 01sep2019 to (b)(6) 2019 since the date of event provided in the form is (b)(6) 2019.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x32mm synergy drug-eluting stent was selected for use.However, during procedure, it was noted that a piece broke inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.(b3) date of event corrected from (b)(6) 2019 to (b)(6) 2019 since the date of event provided in the form is (b)(6) 2019.Device evaluated by mfr.: synergy ii us mr 3.50 x 32mm was returned for analysis.Only the distal end of the device was returned, the manifold containing the stent delivery system number was not returned.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured and the result was within maximum 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 red blood like substance was identified on the outside of the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks and a hypotube break.The break point on the hypotube occurred approximately 121cm proximal from the distal end of tip.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 3.50x32mm synergy drug-eluting stent was selected for use.However, during procedure, it was noted that a piece broke inside the patient.No patient complications were reported.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9205993
• Report Number: 2134265-2019-12319
• Device Sequence Number: 409298
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2019

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 Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023806200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 11/14/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/12/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR