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

Model Number	10603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the obtuse marginal artery.A synergy stent, samurai guidewire, encore balloon, and a comet pressure guidewire were all used during the procedure.While a 2.50 x 20 synergy stent was advanced to the target lesion, the catheter broke.This occurred during the procedure and inside the patient body.All devices were removed and the guide, wire, and inflation device were all still connected.The procedure was completed with a non bsc stent device.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: the stent delivery system (sds) was returned in two parts, one half was within a 6f guide catheter with two guidewires (guidewire outer diameter 0.0140 inches & 0.0105 inches), and an inflation device was attached to the second half of the sds.The device and guidewires were removed distally from the guide catheter without issue.A visual examination of the stent found evidence of damage with struts on both the proximal and distal ends flared.The undamaged crimped stent od (outer diameter) was measured and the result was 0.0380 inches, this is within maximum crimped stent profile measurement.The balloon cones were reviewed, and they appeared in a relaxed state demonstrating that they were subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks and a break 60.9cm distal to the distal end of the strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the obtuse marginal artery.A synergy stent, samurai guidewire, encore balloon, and a comet pressure guidewire were all used during the procedure.While a 2.50 x 20 synergy stent was advanced to the target lesion, the catheter broke.This occurred during the procedure and inside the patient body.All devices were removed and the guide, wire, and inflation device were all still connected.The procedure was completed with a non bsc stent device.No patient complications were reported and the patient status was 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: 8750235
• Report Number: 2134265-2019-07358
• Device Sequence Number: 2043461
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/12/2019

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: 03/25/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023579041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1