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

Lot Number	0032861057
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 70% stenosed target lesion was located in the mildly calcified circumflex artery.A 4.00 x 12mm synergy xd drug eluting stent was advanced for treatment.The balloon was inflated at 12 atmospheres for 20-30 seconds, the stent was deployed but the balloon would not come out.However, the balloon was deflated but it could not be removed and was stuck on the wire.So physician had to pull out everything.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
H3 product analysis anticipated but not begun.
Event or Problem Description
It was reported that device entrapment occurred.The 70% stenosed target lesion was located in the mildly calcified circumflex artery.A 4.00 x 12mm synergy xd drug eluting stent was advanced for treatment.The balloon was inflated at 12 atmospheres for 20-30 seconds, the stent was deployed but the balloon would not come out.However, the balloon was deflated but it could not be removed and was stuck on the wire.So physician had to pull out everything.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 4.00 x 12mm stent delivery system (sds) was returned for analysis.Visual/tactile inspection revealed no issues identified with the hypotube shaft.Microscopic analysis revealed that there was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.The inner lumen was stretched and bunched, 4.6cm proximally from the bumper tip of the device.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The device was returned attached to a 0.0140'' test guidewire.H3 product analysis anticipated but not begun.

• 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: 19406684
• Report Number: 2124215-2024-26900
• Device Sequence Number: 6786521
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2025
• Device Lot Number: 0032861057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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
• Patient Sex: Female
• Patient Race: White