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 Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 16 synergy ii drug eluting coronary stent system was advanced for treatment in a moderately tortuous coronary artery.However, during the procedure the stent dislodged when the device became in contact with the calcium in the coronary artery.The device was removed and no further patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 16 synergy ii drug eluting coronary stent system was advanced for treatment in a moderately tortuous coronary artery.However, during the procedure the stent dislodged when the device became in contact with the calcium in the coronary artery.The device was removed and no further patient complications reported.It was further reported that the target lesion was located in the mildly tortuous and moderately calcified right coronary artery.The device was crushed with another stent and dissection was stented across.The procedure was completed and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy ii us mr 3.00 x 16mm stent delivery system was returned for analysis.The stent was not returned.The crimped stent outer diameter taken at manufacture 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 no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual 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.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 16 synergy ii drug eluting coronary stent system was advanced for treatment in a moderately tortuous coronary artery.However, during the procedure the stent dislodged when the device became in contact with the calcium in the coronary artery.The device was removed and no further patient complications reported.It was further reported that the target lesion was located in the mildly tortuous and moderately calcified right coronary artery.The device was crushed with another stent and dissection was stented across.The procedure was completed and the patient is stable.

• 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: 12128977
• Report Number: 2134265-2021-08640
• Device Sequence Number: 4429189
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0026677922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 08/18/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/14/2021; 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention