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

Model Number	10604
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was defective.The patient came in with st-elevation myocardial infarction.The target lesion was located in a coronary vessel.A 2.25x24mm synergy drug-eluting stent was selected for use.However, upon removing the device, it was noticed that there was a bubble or a metal ring formation on the stent hypotube.The device did not enter the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr.: synergy ii us mr 2.25 x 24 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result 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 tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple 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 visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were noted with the shaft and no anomalies like a bubble was observed.The only "bubble" present is the mid-shaft bond which is part of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the device was defective.The patient came in with st-elevation myocardial infarction.The target lesion was located in a coronary artery.A 2.25 x 24 synergy drug-eluting stent was selected for use; however, when removing the stent from the delivery system, it was noticed that there was a bubble or a metal ring formation on the stent hypotube.The device did not enter the patient's body.The procedure was completed with a different device.No patient complications were reported.

• 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: 10791300
• Report Number: 2134265-2020-15185
• Device Sequence Number: 1088198
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 02/02/2022
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0025210590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR