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

Model Number	10602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that a shaft break occurred.A 3.50 x 16 synergy drug-eluting stent was advanced to treat the lesion.The stent was deployed and during removal, the catheter separated leaving the distal one-fourth behind, mostly in the guide catheter.Another balloon was advanced into the guide and inflated to trap the remaining piece of the stent delivery catheter.The devices were removed together.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.A 3.50 x 16 synergy drug-eluting stent was advanced to treat the calcified lesion.The stent was deployed and during removal, the catheter separated leaving the distal one-fourth behind, mostly in the guide catheter.Another balloon was advanced into the guide and inflated to trap the remaining piece of the stent delivery catheter.The devices were removed together.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.:synergy ii us mr 3.50 x 16mm stent delivery system was returned for analysis.The stent was deployed during the procedure and therefore not returned for analysis.The balloon was inflated, and the distal end of the balloon was noted to be bunched.A visual and microscopic examination of the bumper tip identified no issues.A visual and tactile examination of the hypotube identified multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section identified a shaft break at the wire exit port 119.5cm distal from distal end of strain relief.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: 9395529
• Report Number: 2134265-2019-14723
• Device Sequence Number: 1883372
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024343641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1