MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941828400
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage post deployment occurred and the patient experienced myocardial infarction.The 98% stenosed target lesion was located in the mildly tortuous and mildly calcified left main to left anterior descending (lad) artery.A 4.00 x 28mm synergy xd drug-eluting stent was implanted in the lesion site on july 26th.One day after the procedure, the patient became unstable in intensive care unit (icu), brought back to cath lab and found a clot in the mid lad from a stent deployed a year ago.The physician converted to percutaneous coronary intervention (pci) after angiogram; however, he felt the guide wire was behind the stent struts.Thus, attempted intravascular ultrasound (ivus) and noted that guide wire had caused the stent deformation.The procedure was completed by ballooning, placed a 4.0x38 non-bsc stent and placed an ecmo perfusion catheter.No patient complications were reported and the patient was stable after procedure.
Event or Problem Description
It was reported that stent damage post deployment occurred and the patient experienced myocardial infarction.The 98% stenosed target lesion was located in the mildly tortuous and mildly calcified left main (lm) to left anterior descending (lad) artery.A 4.00 x 28mm synergy xd drug-eluting stent was implanted in the lesion site on july 26th.One day after the procedure, the patient became unstable in intensive care unit (icu), brought back to cath lab and found a clot in the mid lad from a stent deployed a year ago.The physician converted to percutaneous coronary intervention (pci) after angiogram; however, he felt the guide wire was behind the stent struts.Thus, attempted intravascular ultrasound (ivus) and noted that guide wire had caused the stent deformation.The procedure was completed by ballooning, placed a 4.0x38 non-bsc stent and placed an ecmo perfusion catheter.No patient complications were reported and the patient was stable after procedure.
Additional Manufacturer Narrative
Media analysis: five angiographic photos were received by galway cis attached to the complaint record.A review of the photos confirms the alleged stent deformation as proximal stent deformation is noted on a synergy xd stent deployed in the lm to lad.This deformation occurred during the follow up procedure, a day later as the images taken immediately after the stent deployment show no issues and flow restored at lesion site in lm-lad.As per physician's comments this deformation was due to an interaction between the ivus guide and the deployed synergy xd stent brought upon by a misplacement behind the stent struts of the guidewire and causing the ivus device to advance behind the struts and not through the expanded stent as intended.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12330778
• Report Number: 2134265-2021-10053
• Device Sequence Number: 19939688
• Product Code: NIQ
• UDI-Device Identifier: 08714729981152
• UDI-Public: 08714729981152
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/31/2021

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: 01/12/2023
• Device Model Number: H7493941828400
• Device Lot Number: 0026661798
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 63 YR