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

Lot Number	0033526502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The target lesion was located in the mid-left anterior descending (lad) artery and circumflex artery.Following pre-dilation to the mid-lad with a 2.5 x 15 non-boston scientific balloon, a 2.75 x 20mm synergy xd drug-eluting stent was implanted to treat the target lesion.The target lesion was further dilated with a 3.0 x 15 non-bsc balloon, another 3.00 x 20mm synergy xd drug-eluting stent was implanted in the lad and 3.50 x 38mm synergy xd stent was implanted in the circumflex artery.The physician then used two 2.5 x 15 balloon kissing technique to the proximal portions of the stent.The patient was stable and was taken back to the room.After a while, the patient was coded and died.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19617219
• Report Number: 2124215-2024-39311
• Device Sequence Number: 7097086
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2026
• Device Lot Number: 0033526502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White