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

Model Number	10605
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.Device is combination product.
Event or Problem Description
It was reported that the stent was damaged and moved on the balloon.A mr 2.25 x 28mm synergy ii drug eluting stent was advanced, however unable to cross the lesion.During removal of the stent through a watchdog hemostasis valve, the stent was noted to be deformed and came off the balloon a little bit.The procedure was completed using the same watchdog hemostasis valve and another synergy stent of the size.No patient complications were reported and the patient was noted to be fine.
Additional Manufacturer Narrative
(b)(6).Age at time of event: 18 years of age or older.Device is combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 28 mm stent delivery system was returned for analysis.A visual and microscopic examination of the stent found damage to the proximal end of the stent with stent struts lifted and bunched distally.The undamaged crimped stent outer diameter 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 multiple hypotube kinks.A visual and tactile examination of the outer and the 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 the stent was damaged and moved on the balloon.A mr 2.25 x 28mm synergy ii drug eluting stent was advanced, however unable to cross the lesion.During removal of the stent through a watchdog hemostasis valve, the stent was noted to be deformed and came off the balloon a little bit.The procedure was completed using the same watchdog hemostasis valve and another synergy stent of the size.No patient complications were reported and the patient was noted to be fine.

• 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: 8249173
• Report Number: 2134265-2018-65149
• Device Sequence Number: 1607567
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/04/2019

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 Expiration Date: 01/16/2019
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0021644587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WATCHDOG HEMOSTASIS VALVE; WATCHDOG HEMOSTASIS VALVE; WATCHDOG HEMOSTASIS VALVE