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

Model Number	H7493941838350
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced perforation requiring additional intervention.The target lesion was located in the left anterior descending (lad) artery.An impella was placed by the physician, and the lad was advanced with rotawire and ivus and shocked before being successfully stented.The circumflex artery was then addressed, with wiring, ivus, shocking, and nc ballooning performed.A 3.5x38 synergy drug-eluting stent was attempted for delivery, but after multiple attempts and re-ballooning, the stent failed to pass the distal portion of the lesion.After the stent was removed, imaging revealed a perforation.The perforation was tamped with ballooning, and a 2.5x20 no-boston scientific device was used to covered stent and was placed in the mid circumflex artery.An echo and pericardial tap were performed to stabilize the patient.A 3.5x32 synergy was then chosen for the proximal, sealing the perforation.Both devices were removed, and the patient currently remains stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device synergy xd mr us 3.50 x 38mm stent delivery system, catheter was returned to the complaint investigation site (cis) for analysis.Visual and tactile analysis was performed on the device.No kinks or damages on hypotube profile and no issues identified with the outer / mid-shaft sections or the inner lumen of the shaft polymer extrusion profile.Microscopic analysis was performed on the stent profile and there was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.No device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the patient experienced perforation requiring additional intervention.The target lesion was located in the left anterior descending (lad) artery.An impella was placed by the physician, and the lad was advanced with rotawire and ivus and shocked before being successfully stented.The circumflex artery was then addressed, with wiring, ivus, shocking, and nc ballooning performed.A 3.5x38 synergy drug-eluting stent was attempted for delivery, but after multiple attempts and re-ballooning, the stent failed to pass the distal portion of the lesion.After the stent was removed, imaging revealed a perforation.The perforation was tamped with ballooning, and a 2.5x20 no-boston scientific device was used to covered stent and was placed in the mid circumflex artery.An echo and pericardial tap were performed to stabilize the patient.A 3.5x32 synergy was then chosen for the proximal, sealing the perforation.Both devices were removed, and the patient currently remains stable.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21124651
• Report Number: 2124215-2024-82736
• Device Sequence Number: 20752927
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 01/03/2026
• Device Model Number: H7493941838350
• Device Catalogue Number: H7493941838350
• Device Lot Number: 0033157286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White