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

Model Number	10607
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the calcified mid right coronary artery.A 4.00 x 38 mm synergy ii drug eluting stent was selected, however the device was unable to be advanced through the calcium.During removal the stent got caught inside the guidezilla on the distal area when it was pulled back.Both the stent and the guidezilla was removed form the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 38mm stent delivery system was returned for analysis loaded and stuck in a 6 fr guidezilla extension catheter.An examination of the crimped stent identified stent damage.Damage was observed on the proximal section of the stent with the stent struts bunched.The crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.The device could not be removed from the guide catheter extension due to the damaged stent.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A red blood like substance was identified on the outside of the balloon.A visual and tactile examination of the hypotube identified multiple kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination identified tip damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that difficulty removal occurred.The taret lesion was located in the calcified mid right coronary artery.A 4.00 x 38mm synergy ii drug elutng stent was selected, however the device was unable to be advanced through the calcium.During removal the stent got caught inside the guidezilla on the distal area when it was pulled back.Both the stent and the guidezilla was removed form the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient 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: 9078730
• Report Number: 2134265-2019-10747
• Device Sequence Number: 16757313
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 10/29/2019

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 Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0023804565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR