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

Model Number	10602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occured.A 3.50mm x 16mm synergy drug-eluting stent (des) was advanced for treatment.The stent shaft broke prior to entering the body.The procedure was completed with different device.There were no patient complications nor injuries were reported.
Event or Problem Description
It was reported that shaft break occured.A 3.50mm x 16mm synergy drug-eluting stent (des) was advanced for treatment.The stent shaft broke prior to entering the body.The procedure was completed with different device.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluate by mfr.: synergy ii us mr 3.50 x 16 mm stent delivery system was returned for analysis.Only the distal section of the device was returned including the stent, mid- shaft and the shaft polymer extrusion.The proximal device including the hypotube and manifold were not returned for analysis.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 markerbands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were identified.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip found no issues.The hypotube shaft was not returned.A break in the shaft polymer extrusion was noted at 35 cm distal from the distal end of the tip.No other damages were noted to the mid- shaft, inner lumen or outer lumen sections of the shaft.No other issues were identified during the product analysis.

• 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: 8748873
• Report Number: 2134265-2019-06929
• Device Sequence Number: 1999497
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/24/2019

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 Expiration Date: 03/27/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023642225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR