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

Model Number	10603
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the circumflex artery.A 2.75 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and the proximal edge of the stent was noted to be damaged.The procedure was completed with another 2.75 x 20 stent.No patient complications were reported and the patient was doing well.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the circumflex artery.A 2.75 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and the proximal edge of the stent was noted to be damaged.The procedure was completed with another 2.75 x 20 stent.No patient complications were reported and the patient was doing well.Synergy ii us mr 2.75 x 20mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified proximal and distal stent damage.The proximal end of the stent was damaged with stent struts bunched distally.The distal end of the stent was damaged with stent struts stretched distally over the distal markerband.The undamaged mid crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon did not appear to have been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/12/2018 03:35 pm ct.The report number is being corrected from: 2134265-2018-63970 to: 2134265-2018-62719.

• 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: 8053657
• Report Number: 2134265-2018-62719
• Device Sequence Number: 1787679
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/24/2019

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: 07/25/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0022457210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR