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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2019
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 3.50 x 12 synergy drug-eluting stent was selected for use.However, during preparation, it was noticed that the hypotube broke.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.50 x 12 mm stent delivery system was returned for analysis broken in 2 pieces.A visual examination of the stent found signs of stent damage.Stent struts on the mid stent strut row was noted to be lifted and pulled in a distal direction.The undamaged stent outer diameter was within max 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 210 mm 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.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 12 synergy drug-eluting stent was selected for use.However, during preparation, it was noticed that the hypotube broke.The procedure was completed with another of the same device.

• 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: 9391894
• Report Number: 2134265-2019-14105
• Device Sequence Number: 10896232
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023246870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1