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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00x16mm synergy drug-eluting stent was selected for use.However, the stent came off from the delivery system outside the patient's body.Subsequently, a 3.5x12mm synergy stent was advanced but failed to cross the lesion.It was noted that the stent struts had fractured.The procedure was completed with 3 additional synergy stents.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 16 mm stent delivery system was returned for analysis.A visual examination of the stent found the stent was received detached from the delivery system.Stent struts on the mid-section and proximal region of the stent were lifted.A review of the stent profile was performed.The crimped stent outer diameter at the time of manufacturing was within maximum crimped stent profile measurement.The balloon body was reviewed; and no issues were noted.There was no stent on the balloon body.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Stent crimp markings were visible on the balloon body which is an indication that the stent was crimped to the balloon prior to detachment.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found no issue with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 4.00x16mm synergy drug-eluting stent was selected for use.However, the stent came off from the delivery system outside the patient's body.Subsequently, a 3.5x12mm synergy stent was advanced but failed to cross the lesion.It was noted that the stent struts had fractured.The procedure was completed with 3 additional synergy stents.No patient complications were reported.

• 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: 9962175
• Report Number: 2134265-2020-04366
• Device Sequence Number: 2794273
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/28/2020

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: 09/09/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024442846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1