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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date was not provided, used (b)(6) 2020 as date of event.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.It was then noted that the device was fractured.The procedure was completed with another of the same device.No known patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.It was then noted that the device was fractured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: date was not provided, used (b)(6) 2020 as date of event.Device evaluation by mfr.: synergy ii us mr 3.00 x 20mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the distal end of the stent were lifted and pulled distally.The undamaged stent outer diameter 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 distal tip damage.A visual and tactile examination of the hypotube found two hypotube kinks at 1mm and 740mm 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 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: 10375040
• Report Number: 2134265-2020-09721
• Device Sequence Number: 14233159
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 10/09/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024609759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1