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

Model Number	10602
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Age at time of event: above 18 years and older.
Event or Problem Description
It was reported that the synergy device dislodged inside the guidezilla ii during removal.The target lesion was located in the highly calcified left anterior descending artery.A 6f guidezilla ii guide catheter was use to advanced a 2.75 x 16 synergry drug-eluting stent to treat the lesion.However, it failed to cross the lesion even after multiple attempts.When the stent was pulled back into the guidezilla, it hung up and broke off the balloon.Everything was removed from the patient's body and completed the procedure with another of the same device.There were no patient complications reported and the patient was fine.
Event or Problem Description
It was reported that the synergy device dislodged inside the guidezilla ii during removal.The target lesion was located in the highly calcified left anterior descending artery.A 6f guidezilla ii guide catheter was use to advanced a 2.75 x 16 synergry drug-eluting stent to treat the lesion.However, it failed to cross the lesion even after multiple attempts.When the stent was pulled back into the guidezilla, it hung up and broke off the balloon.Everything was removed from the patient's body and completed the procedure with another of the same device.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.A2: age at time of event: above 18 years and older.Device evaluated by mfr.: synergy ii us mr 2.75 x 16 mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that the stent had moved on balloon distally, the proximal section of the stent was covering the distal markerband and the stent struts were stretched over the tip.The stent was severely damaged the whole length with stent struts stretched.As part of the analysis, a review of the manufacturing data for the stent profile was performed.The maximum crimped stent profile measurement at the time of manufacture.This measurement is within the specification.Stent movement on balloon and stent damage most likely occurred when the stent interacted the distal section of the guidezilla when the stent was being withdrawn into the guidezilla after the stent had failed to cross the lesion.A visual examination of the tip showed no signs of damage.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.Crimp stent markings were visible on the exposed balloon body.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found no issues with the extrusion shaft.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: 9410809
• Report Number: 2134265-2019-14924
• Device Sequence Number: 19566575
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/10/2020

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: 08/27/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024394643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1