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

Model Number	10600
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the ostial diagonal lesion.A 2.50 x 8 synergy drug-eluting stent was placed but missed the ostium so a second 2.50 x 8 synergy drug-eluting stent was placed more proximal to cover the ostial lesion.An emerge balloon catheter was then advanced in the left anterior descending artery (lad) and performed a crush to the ostium of the diagonal stent.Another stent was then placed in the lad covering the ostium.Video showed the second ostial stent in place after the lad stent was deployed.There was no further intervention but when angiography was taken, it was noted that the ostial diagonal stent had randomly moved distally, into the first stent.The procedure was stopped.There was no harm to the patient.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the ostial diagonal lesion.A 2.50 x 8 synergy drug-eluting stent was placed but missed the ostium so a second 2.50 x 8 synergy drug-eluting stent was placed more proximal to cover the ostial lesion.An emerge balloon catheter was advanced in the left anterior descending artery (lad) and performed a crush to the ostium of the diagonal stent.Another stent was then placed in the lad covering the ostium.Video showed the second ostial stent in place after the lad stent was deployed.There was no further intervention but when angiography was taken, it was noted that the ostial diagonal stent had randomly moved distally, into the first stent.The procedure was stopped.There was no harm to the patient.
Additional Manufacturer Narrative
Media reviewed by boston scientific medical personnel: procedural angiographic media was provided to assist in the investigation and was reviewed by boston scientific medical personnel.The media made available for review is not consistent with the reported event.The media revealed that the left anterior descending artery (lad) and diagonal (dg) bifurcation was stented using crush technique.Geographic miss of dg ostium.A guide catheter became disengaged at some time after the lad stent was deployed.Case concluded with evidence of longitudinal stent deformation involving the dg stent.There was no evidence of stent migration.The provided images are not consistent with the event of stent migration.The images are consistent with longitudinal stent deformation.Loss of guide catheter access and resulting interaction with ancillary equipment while re-accessing the vessel may have contributed to the stent deformation.

• 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: 11771266
• Report Number: 2134265-2021-05542
• Device Sequence Number: 11539308
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: 08714729839972
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/10/2021

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: 08/07/2022
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0025873397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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