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

Model Number	10602
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.It was further reported that vascular access was obtained via the radial artery and that the lesion was pre-dilated with a balloon.It was noted that there were multiple attempts made to position the stent at the lesion site.Device interaction with a previously deployed stent which caused the dislodgement was also noted.
Additional Manufacturer Narrative
H6- patient codes: device embedded in tissue or plaque.H6- device codes: device-device incompatibility.
Additional Manufacturer Narrative
H6 patient codes corrected.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.It was further reported that vascular access was obtained via the radial artery and that the lesion was pre-dilated with a balloon.It was noted that there were multiple attempts made to position the stent at the lesion site.Device interaction with a previously deployed stent which caused the dislodgement was also noted.It was further reported via medwatch 2900390000-2021-8001 that the patient was brought emergently for st elevation myocardial infarction reperfusion.The patient underwent diagnostic coronary angiography, left heart catheterization, left ventriculogram, and percutaneous coronary intervention (pci).The stent was dislodged from the balloon in the ostial left circumflex artery.A vascular surgeon was consulted but no surgical intervention was required.The stent was left in the distal radial artery.

• 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: 11163730
• Report Number: 2134265-2021-00133
• Device Sequence Number: 845980
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025761500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/27/2021; 02/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/17/2021; 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 66