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

Model Number	H7493941820220
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty occurred and the patient experienced arrhythmia.The 100% occluded target lesion was located in the mildly tortuous and non-calcified obtuse marginal branch.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The stent was deployed, however, upon pulling negative, the balloon appeared to be stuck on the stent.The balloon was reinflated at low atmospheres and deflated slowly walking down the pressure.The balloon remained stuck to the stent even after multiple negatives pulled on stent delivery system (sds).The physician also attempted to push balloon forward and backward, however, the balloon remained stuck.A buddy wire was advanced to sds, but still there was no change.Subsequently, a guide advanced over the system to location of stuck stent balloon, balloon then pulled back and into guide and removed intact.Patient then became unstable.Repeat balloon inflations with a new balloon to stent were performed.Many attempts to remove the stent balloon possibly led to thrombosis and the patient experienced arrhythmia.In the physician's opinion, the device or procedure contributed to patient complications which led for repeat percutaneous coronary intervention (pci).No further patient complications were reported and the issue is ongoing.
Additional Manufacturer Narrative
Device evaluated by mfr.Synergy xd mr us 2.25 x 20mm stent delivery system (sds); catheter was returned for analysis.A visual, tactile examination identified multiple kinking along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A microscopic examination identified multiple kinking along the length of the hypotube shaft.Further microscopic examinations identified a break in the lasercut region.The break was located approximately 13cm proximal from the guidewire exchange port.Both sections of the break were held together in the midshaft extrusion.A microscopic examination of the balloon identified no damage.There were traces of contrast media present inside the balloon.A microscopic examination of the bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that removal difficulty occurred and the patient experienced arrhythmia.The 100% occluded target lesion was located in the mildly tortuous and non-calcified obtuse marginal branch.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.The stent was deployed, however, upon pulling negative, the balloon appeared to be stuck on the stent.The balloon was reinflated at low atmospheres and deflated slowly walking down the pressure.The balloon remained stuck to the stent even after multiple negatives pulled on stent delivery system (sds).The physician also attempted to push balloon forward and backward, however, the balloon remained stuck.A buddy wire was advanced to sds, but still there was no change.Subsequently, a guide advanced over the system to location of stuck stent balloon, balloon then pulled back and into guide and removed intact.Patient then became unstable.Repeat balloon inflations with a new balloon to stent were performed.Many attempts to remove the stent balloon possibly led to thrombosis and the patient experienced arrhythmia.In the physician's opinion, the device or procedure contributed to patient complications which led for repeat percutaneous coronary intervention (pci).No further patient complications were reported and the issue is ongoing.

• 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: 16526461
• Report Number: 2124215-2023-08886
• Device Sequence Number: 14108517
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: 08714729980735
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: H7493941820220
• Device Lot Number: 0029192231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown