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

Model Number	10606
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties were encountered and shaft break occurred.Following pre-dilatation, a 3.50 x 32mm synergy ii drug-eluting stent was deployed.However, while attempting to remove the delivery system, resistance was encountered.On the second attempt, the shaft broke.The broken device was able to be retrieved into the guide and was completely removed together with the guide catheter.The implanted stent was not damaged and the procedure was completed with another guide with good final result.No patient complications were reported.The physician reported he might have pulled back on the device prior to the balloon being fully deflated.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.50 x 32mm stent delivery system was returned for analysis.The stent was deployed in the procedure and was not returned.The balloon appeared partially deflated, with the distal balloon cone bunched distally.A dried red-like substance was noted on 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.A visual examination of the outer and inner lumen and mid-shaft section found multiple polymer extrusion kinks and a shaft break 121.6cm distal to the distal end of the strain relief, close to the port bond site.The port bond area was stretched and the outer clear shaft was stretched proximal to the break site, with the core-wire exposed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered and shaft break occurred.Following pre-dilatation, a 3.50 x 32mm synergy ii drug-eluting stent was deployed.However, while attempting to remove the delivery system, resistance was encountered.On the second attempt, the shaft broke.The broken device was able to be retrieved into the guide and was completely removed together with the guide catheter.The implanted stent was not damaged and the procedure was completed with another guide with good final result.No patient complications were reported.The physician reported he might have pulled back on the device prior to the balloon being fully deflated.

• 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: 9035375
• Report Number: 2134265-2019-10600
• Device Sequence Number: 16617159
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/07/2019

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: 08/12/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0022547869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1