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

Model Number	10604
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred.The target lesion was located in a coronary artery.A 4.00 x 24 synergy drug-eluting stent was advanced for treatment.After placing the stent, it was noted that the stent balloon kept on getting caught on the guide when attempting to be removed and the balloon would not deflate properly.The physician then removed all the devices in order to removed the balloon.There were no patient complications nor injuries reported and the patient's status was fine.
Additional Manufacturer Narrative
Synergy ii us mr 4.00 x 24mm stent delivery system was returned for analysis without the stent.A visual examination of the stent found that the stent was not returned as it was positioned and deployed successfully at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as its wings were relaxed and not tightly folded.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The device was placed in water bath overnight for soaking pre-inflation test.The device was loaded onto a guide wire and loaded into a test guide catheter without issue.The balloon was inflated using a pressure of 16 atm with no issues.Vacuum was pulled and the balloon deflated in 08 seconds with no issues.The device was withdrawn into a guide catheter and removed without issue.The encore inflation device was verified before and after use up to 16 atm using a druck gauge.No issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred.The target lesion was located in a coronary artery.A 4.00 x 24 synergy drug-eluting stent was advanced for treatment.After placing the stent, it was noted that the stent balloon was getting caught on the guide when attempting to be removed and the balloon would not deflate properly.The physician then removed all the devices in order to remove the balloon.There were no patient complications nor injuries reported and the patient's status was fine.

• 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: 10310521
• Report Number: 2134265-2020-08964
• Device Sequence Number: 3246906
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/18/2020

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: 09/09/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024455130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: MERIT.; INFLATION DEVICE: MERIT.