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

Model Number	10604
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment and shaft break occurred.The target lesion was located in a coronary vessel.A 4.00x24mm synergy drug-eluting stent was advanced to treat the lesion.However, when pullback was attempted for correct placement of the device, the stent did not come back and the shaft broke inside the guide.The guide was removed and the stent was removed with a snare.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 4.00 x 24mm stent delivery system was returned for analysis in 2 pieces.A visual and microscopic examination of the stent found proximal stent damage, with stent struts lifted.The undamaged stent outer diameter was measured 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 a hypotube break located 46.7cm distal to the distal strain relief, measured using ruler, as well as multiple hypotube kinks at several locations along the hypotube shaft.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 dislodgment and shaft break occurred.The target lesion was located in a coronary vessel.A 4.00x24mm synergy drug-eluting stent was advanced to treat the lesion.However, when pullback was attempted for correct placement of the device, the stent did not come back and the shaft broke inside the guide.The guide was removed and the stent was removed with a snare.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the physician did not snared the stent.The shaft broke inside the guide before entering the coronary artery and used a balloon to trap all devices and pulled everything out as one unit inside the guide.

• 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: 9734248
• Report Number: 2134265-2020-01586
• Device Sequence Number: 19433244
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/20/2020

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: 09/09/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024455130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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