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

Model Number	10602
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.75 x 16 stent delivery system was returned for analysis.Device was returned with guidezilla 6fr.A visual examination of the stent found stent damage.Distal region of the stent was bunched.The undamaged stent 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 and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of tip damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A recommended 0.014 inch guidewire was loaded without issue.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 19-oct-2020.It was reported that crossing and advancing difficulties occurred.The 80-90% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 2.75 x 16 synergy drug eluting stent was advanced to treat the lesion.However, during procedure the stent failed to cross and was withdrawn from the body without issue.A guidezilla guide extension catheter was then advanced but when the stent was re-inserted, it was unable to advance through the guidezilla.The case was not lengthened and the patient was not harmed.However, returned device analysis revealed stent damage.

• 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: 10801242
• Report Number: 2134265-2020-15463
• Device Sequence Number: 3266951
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 10/20/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024726201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1