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

Model Number	10603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date the incident occurred was estimate as (b)(6) 2019 which is the first day of the month of the aware date.Device is combination product.
Event or Problem Description
It was reported that stent dislodge occurred.A 2.50 x 20 synergy drug-eluting stent was selected and advanced for treatment.However, it was noted that the back of the stent came off and could not be deployed.No further patient complications were reported.
Event or Problem Description
It was reported that stent dislodge occurred.A 2.50 x 20 synergy drug-eluting stent was selected and advanced for treatment.However, it was noted that the back of the stent came off and could not be deployed.No further patient complications were reported.
Additional Manufacturer Narrative
Date the incident occurred was estimate as (b)(6) 2019 which is the first day of the month of the aware date.Device is combination product.Device evaluated by mfr: synergy ii us mr 2.50 x 20 mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Stent struts from 1st proximal stent strut rows were noted to be lifted from their crimped position and pulled in distally.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.An examination (visual and via scope) found no issues with the tip.A visual and tactile examination of the hypotube found multiple hypotube kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.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.

• 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: 8847973
• Report Number: 2134265-2019-08517
• Device Sequence Number: 16756075
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 08/01/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1