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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesions were located in the severely tortuous and severely calcified proximal circumflex artery.After an emerge 2.0 x 12mm balloon catheter was advanced for pre-dilation, a 2.25mm x 16mm synergy ii drug-eluting stent was advanced for treatment but was unable to track the device through the distal left main (lm) into the proximal circumflex.The device was then removed and was re-advanced with a 6f guidezilla guide support catheter but still failed to cross the distal lm.Upon pulling the device, a stent strut caught the edge of a plaque shift in the distal lm causing the stent to be dislodged from the balloon delivery system.Subsequently, the physician inserted a 1.2x10mm non-bsc balloon catheter through the dislodged stent and successfully retrieved it.The procedure was then completed by deploying two 2.25x12mm promus elite stents into the target lesion.There were no patient complications nor adverse events reported and the patient was discharged the following day.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was returned for analysis.A damaged synergy stent was returned for analysis on a non-bsc (medtronic 1.25 x15mm) stent delivery system.Entire length of stent damaged.After visual inspection via the microscope, two-connectors on the distal end and four-connectors on the proximal end were identified which are characteristics of a synergy stent.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesions were located in the severely tortuous and severely calcified proximal circumflex artery.After an emerge 2.0 x 12mm balloon catheter was advanced for pre-dilation, a 2.25mm x 16mm synergy ii drug-eluting stent was advanced for treatment but was unable to track the device through the distal left main (lm) into the proximal circumflex.The device was then removed and was re-advanced with a 6f guidezilla guide support catheter but still failed to cross the distal lm.Upon pulling the device, a stent strut caught the edge of a plaque shift in the distal lm causing the stent to be dislodged from the balloon delivery system.Subsequently, the physician inserted a 1.2x10mm non-bsc balloon catheter through the dislodged stent and successfully retrieved it.The procedure was then completed by deploying two 2.25x12mm promus elite stents into the target lesion.There were no patient complications nor adverse events reported and the patient was discharged the following day.

• 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: 8728745
• Report Number: 2134265-2019-07349
• Device Sequence Number: 11227489
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/01/2019

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: 02/19/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023413511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR