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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
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 90% stenosed target lesion was located in the mid circumflex artery.A 2.75 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, the stent was unable to get through the watchdog hemostasis valve and when the device was removed, the stent was not mounted on the balloon.The deployment system was removed through watchdog with the stent still on deployment system.The procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the mid circumflex artery.A 2.75 x 28mm synergy ii drug-eluting stent was advanced for treatment.However, the stent was unable to get through the watchdog hemostasis valve and when the device was removed, the stent was not mounted on the balloon.The deployment system was removed through watchdog with the stent still on deployment system.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Synergy ii us mr 2.75 x 28 stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent strut rows 1 to 14 from the proximal end of the stent appear undamaged.The remainder of the stent is damaged and stretched in a distal direction extending 12mm past the distal end of the distal markerband.The proximal end of the stent showed no sign of movement on the balloon as it appeared to be crimped in position.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The balloon was 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 tactile examination of the hypotube identified multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues with the tip.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: 8429460
• Report Number: 2134265-2019-02560
• Device Sequence Number: 1341337
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: 08714729840282
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/24/2019

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: 02/28/2019
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0021864156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1