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

Model Number	10603
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 20 synergy drug-eluting stent was advanced for treatment.However, upon loading the stent onto the wire, resistance was felt and was noted that the stent delivery system broke.The procedure was completed with a different device with no complications.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 20 synergy drug-eluting stent was advanced for treatment.However, upon loading the stent onto the wire, resistance was felt and was noted that the stent delivery sytem broke.The procedure was completed with a different device with no complications.It was further reported that the stent was pulled off the delivery catheter while the physician was trying to take the catheter off the wire.
Additional Manufacturer Narrative
Device is a combination product.(f10) device code- added device dislodged or dislocated.Device evaluated by mfr.: synergy ii us mr 2.50 x 20mm stent delivery system (sds) was returned for analysis the device was returned with the stent detached from the balloon.As a result, the crimped stent outer diameter could not be measured.The maximum stent profile for sds was within maximum crimped stent profile measurement.The balloon was not inflated, and crimp marks were evident on the balloon.The balloon folds were relaxed and inner polymer extrusion bunching was noted in the balloon area.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 117.5cm distal from distal end of strain relief.With the core wire exposed.The inner polymer extrusion was also bunched in balloon area.The guidewire used by the customer was not returned for analysis.A 0.014 inch guidewire could not be loaded due to the inner polymer extrusion bunching in balloon area and the shaft break.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: 9404215
• Report Number: 2134265-2019-14424
• Device Sequence Number: 2606523
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/24/2020

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 Expiration Date: 05/26/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023922381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1