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

Model Number	10602
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
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.The target lesion was located in the left anterior descending artery.A 2.50 x 16mm synergy ii drug-eluting stent was advanced for treatment.However, after the stent was expanded and placed, stickiness or resistance was noted when they went to withdraw the balloon from the stent.The device was pulled a little harder and was removed.The procedure was normally completed with this device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 2.50 x 16 mm stent delivery system was returned for analysis.No stent was returned for analysis.A review of the manufacturing stent profile data was performed and the stent od at the time of manufacture was within maximum crimped stent profile measurement.It appeared that the positive pressure had been applied to the balloon as it was returned in a deflated state.A visual and microscopic examination of the bumper tip identified damage to the distal edge of the tip.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer lumen and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.A recommended 0.014 test guidewire was loaded through the tip without issue to facilitate functional testing.The balloon was inflated to rated burst pressure without issue.The device was deflated successfully within specification.Deflation time was measured.The encore inflation device was verified before and after use.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the left anterior descending artery.A 2.50 x 16mm synergy ii drug-eluting stent was advanced for treatment.However, after the stent was expanded and placed, stickiness or resistance was noted when they went to withdraw the balloon from the stent.The device was pulled a little harder and was removed.The procedure was normally completed with this device.No patient complications were 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: 8773856
• Report Number: 2134265-2019-07450
• Device Sequence Number: 2043926
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 04/08/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023656270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR