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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.Vascular access was obtained via the right femoral artery.The 90% target lesion was located in the non tortuous and mildly calcified mid left anterior descending artery (lad).Both lad and diagonal branch artery were wired with a non bsc guide wire.A 2.50 x 28 synergy ii drug-eluting stent was selected for use.The device was prepared by flushing with saline through the tip of the stent for 5 seconds to the wire lumen of the monorail segment.The scrub did not applied negative pressure or a syringe on the stent before handling it to the physician.The stent was inserted into the guidewire through the touhy in the lad artery.The device was advanced but the physician felt resistance approximately half way down.The scrub pulled a slight negative pressure on the stent with the endoflator to aid the resistance.However, the tip of the stent never exited the guide to enter into the coronary artery.So, the stent delivery system was removed from the guide catheter and it was noted that the stent was no longer on the delivery system after it was pulled out from the patient's body.The physician used fluoroscopy to look for the stent in the guide catheter but it was not visible anywhere.The tuohy was removed from the back of the guide catheter over the lad wire which was still inside the patient's body.The stent then fell out from the tuohy over the wire that was inserted from the lad and was flushed.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device is evaluated b y mfr.: synergy ii us mr 2.50 x 28 stent delivery system was returned for analysis.The detached stent was not returned.The stent was detached from the balloon.The balloon folds appeared relaxed; however, it does not appear that the balloon was subjected to positive pressure.Crimp markings were evident on the balloon.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination found no issues with the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.Vascular access was obtained via the right femoral artery.The 90% target lesion was located in the non tortuous and mildly calcified mid left anterior descending artery (lad).Both lad and diagonal branch artery were wired with a non bsc guide wire.A 2.50 x 28 synergy ii drug-eluting stent was selected for use.The device was prepared by flushing with saline through the tip of the stent for 5 seconds to the wire lumen of the monorail segment.The scrub did not applied negative pressure or a syringe on the stent before handling it to the physician.The stent was inserted into the guidewire through the tuohy in the lad artery.The device was advanced but the physician felt resistance approximately halfway down.The scrub pulled a slight negative pressure on the stent with the endoflator to aid the resistance.However, the tip of the stent never exited the guide to enter into the coronary artery.So, the stent delivery system was removed from the guide catheter and it was noted that the stent was no longer on the delivery system after it was pulled out from the patient's body.The physician used fluoroscopy to look for the stent in the guide catheter but it was not visible anywhere.The tuohy was removed from the back of the guide catheter over the lad wire which was still inside the patient's body.The stent then fell out from the tuohy over the wire that was inserted from the lad and was flushed.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: 8463915
• Report Number: 2134265-2019-02980
• Device Sequence Number: 1288436
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/13/2019

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: 10/14/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022837326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: GUIDEZILLA 2; GUIDE CATHETER: GUIDEZILLA 2; GUIDEWIRE: PROWATER; GUIDEWIRE: PROWATER; GUIDE CATHETER: GUIDEZILLA 2; GUIDEWIRE: PROWATER