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

Model Number	10602
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	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon deflation issue and difficulty removal was encountered.The target lesion was located in a coronary artery.A 4.00 x 16 synergy drug-eluting stent was deployed to treat the lesion.After deployment the balloon appeared to deflate.However, the stent balloon was unable to be removed back into the guide.The physician sucked back on the indeflator multiple times to get the balloon deflated but unable to get the balloon to deflate completely.The devices were then removed together in order to remove the balloon from the patient's body.The physician then engaged the coronary again and the procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that balloon deflation issue and difficulty removal was encountered.The target lesion was located in a coronary artery.A 4.00 x 16 synergy drug-eluting stent was deployed to treat the lesion.After deployment the balloon appeared to deflate.However, the stent balloon was unable to be removed back into the guide.The physician sucked back on the indeflator multiple times to get the balloon deflated but unable to get the balloon to deflate completely.The devices were then removed together in order to remove the balloon from the patient's body.The physician then engaged the coronary again and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 16mm 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.The distal section of the balloon is slightly bunched.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found bunching/accordion of the distal inner 6.5cm proximal to the distal end of the tip.The device was placed in water bath overnight for soaking pre-inflation test.The device was loaded onto a 0.014'' 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 9 seconds with no issues.The device was withdrawn into guide catheter and removed without issue.The encore inflation device was verified before and after use up to 16 atm using druck gauge.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: 10290274
• Report Number: 2134265-2020-08989
• Device Sequence Number: 19623642
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024442846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1