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

Model Number	10601
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that stent damage occurred.A 3.50x12 synergy stent was advanced in a guide catheter.The physician felt resistance and removed the device.The balloon edges (proximal and distal) appeared larger than what they were supposed to be and weren't tightly crimped or wrapped, it appeared to be almost pre-dilated.The physician stated that the stent looked damaged.Another 3.5x12 synergy mr was used to complete the procedure.There were no patient injury reported and the patient's condition was stable.
Event or Problem Description
It was reported that stent damage occurred.A 3.50x12 synergy stent was advanced in a guide catheter.The physician felt resistance and removed the device.The balloon edges (proximal and distal) appeared larger than what they were supposed to be and weren't tightly crimped or wrapped, it appeared to be almost pre-dilated.The physician stated that the stent looked damaged.Another 3.5x12 synergy mr was used to complete the procedure.There were no patient injury reported and the patient's condition was stable.Synergy ii us mr 3.50 x 12 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found distal stent damage on the first stent strut row, stent struts were pushed and lifted.The undamaged distal section stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and both the distal end and proximal end were bunched.The bunching was most likely due to the excessive force that could have been applied during advancing attempts.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of damage at the distal ends of the tip.A visual and tactile examination of the hypotube found a hypotube kink 380 mm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is combination product.

• 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: 7916199
• Report Number: 2134265-2018-61381
• Device Sequence Number: 10976988
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/02/2018

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: 06/25/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022329228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1