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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal left anterior descending artery.A 2.25 x 16 synergy drug-eluting stent was selected to treat the lesion but difficulty crossing the lesion encountered.The physician was trying to push it forward and then decided to pullout the device the balloon came and the undeployed stent got stuck in a proximal lesion.The undeployed stent was snared out.The procedure was completed with different device.No patient complications were reported and the patient is fine.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal left anterior descending artery.A 2.25 x 16 synergy drug-eluting stent was selected to treat the lesion but difficulty crossing the lesion encountered.The physician was trying to push it forward and then decided to pullout the device the balloon came and the undeployed stent got stuck in a proximal lesion.The undeployed stent was snared out.The procedure was completed with different device.No patient complications were reported and the patient is fine.
Additional Manufacturer Narrative
Device is combination product device evaluated by mfr.: synergy stent delivery system was returned for analysis.A visual examination found the stent was detached from the balloon.It did not appear to be expanded.The crimped stent outer diameter measured at manufacturer and was within maximum crimped stent profile measurement.The balloon cones were reviewed, and the balloon cone folds were present but did not appear tightly folded.Crimp markings were evident on the exposed balloon wall.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.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.

• 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: 9602364
• Report Number: 2134265-2020-00234
• Device Sequence Number: 19323934
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/03/2020

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: 04/08/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023650419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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