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

Model Number	10604
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon removal difficulties were encountered.The target lesion was located in the right coronary artery.A 4.00mm x 24mm synergy drug-eluting stent was advanced for treatment.The stent was deployed at 12 atmospheres and the balloon was deflated.However, it was observed that the balloon was sticking to the stent.When the balloon was inflated again to 16 atmospheres, it was still stuck.The balloon was tugged hard and removed from the patient's body.No issue was noted with the implanted stent and it was fully deployed and expanded.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that balloon removal difficulties were encountered.The target lesion was located in the right coronary artery.A 4.00mm x 24mm synergy drug-eluting stent was advanced for treatment.The stent was deployed at 12 atmospheres and the balloon was deflated.However, it was observed that the balloon was sticking to the stent.When the balloon was inflated again to 16 atmospheres, it was still stuck.The balloon was tugged hard and removed from the patient's body.No issue was noted with the implanted stent and it was fully deployed and expanded.No patient complications were reported and the patient's status was fine.Device evaluated by mfr.: synergy ii us mr 4.00 x 24mm stent delivery system (sds) was returned for analysis inside the guide catheter and tracked over a guidewire.There was no stent returned with the sds.The balloon was severely damaged.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found the shaft to be broken at the site of the port bond.The location of the break at the port corresponded with a severe kink which was noted in the guide catheter which had prevented the investigator from removing the sds with ease.The kink in the guide catheter measured 701mm distal from the distal end of the guide catheters strain relief.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is a combination product.

• 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: 7895645
• Report Number: 2134265-2018-61152
• Device Sequence Number: 1909523
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/08/2018

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: 01/04/2019
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0021596897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1