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

Model Number	10600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age of time of event: 18 years or older.Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the left anterior descending artery.A 4.00 x 8 synergy drug-eluting stent was advanced for treatment.However, it was noted the stent came off the delivery system and was not found under fluoroscopy.When the guide catheter and sheath was pulled out, the stent was found and retrieved.The procedure was completed with a different device.No patient complications were reported and the patient was okay.
Additional Manufacturer Narrative
Age of time of event: 18 years or older.Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 8 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found that the stent was dislodged from the balloon and damaged.A review of the manufacturing stent profile data was within max 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 damage at the distal end of the tip.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a tear in the outer shaft polymer extrusion located at the guidewire exchange port region.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the left anterior descending artery.A 4.00 x 8 synergy drug-eluting stent was advanced for treatment.However, it was noted the stent came off the delivery system and was not found under fluoroscopy.When the guide catheter and sheath was pulled out, the stent was found and retrieved.The procedure was completed with a different device.No patient complications were reported and the patient was okay.

• 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: 9355602
• Report Number: 2134265-2019-14015
• Device Sequence Number: 14008060
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: 08714729840015
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/26/2019

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 Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0022250715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1