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

Model Number	10604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the right radial artery.The target lesion was located in the mid right coronary artery.A 2.50x24mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and the shaft broke at approximately 15-20cm from the hub.The device was removed and the procedure was completed with another 2.50x24mm synergy stent.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the right radial artery.The target lesion was located in the mid right coronary artery.A 2.50x24mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and the shaft broke at approximately 15-20cm from the hub.The device was removed and the procedure was completed with another 2.50x24mm synergy stent.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.A synergy ii us mr 2.50 x 24 mm stent delivery system was returned for analysis broken in 2 pieces.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result 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 signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft found a break situated at 15 cm distal to the distal end of the strain relief as well as multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen 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: 9235212
• Report Number: 2134265-2019-12957
• Device Sequence Number: 398200
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/29/2019

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: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023661624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR