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

Model Number	H7493941848250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent left heart catheterization (lhc).A 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon ruptured at 4-6 atmospheres.The stent was then removed undeployed and was still on the stent balloon.The procedure was completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
Date of event- used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
D4 updated: lot number from unknown to 0028474873.B3 date of event updated from unknown to 03/28/2023.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent left heart catheterization (lhc).A 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon ruptured at 4-6 atmospheres.The stent was then removed undeployed and was still on the stent balloon.The procedure was completed with a different device, and no patient complications were reported.It was further reported that the stenosed target lesion was 90%, located in the non-tortuous and moderate to severely calcified mid and distal left anterior descending artery.Initial inflation was attempted but the balloon ruptured before the stent was even able to be expanded.The device was removed from the body and the stent was still wrapped on the balloon.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.50 x 48mm was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.The hypotube was broken at the distal end of the manifolds strain relief.A visual examination of the outer and inner lumen and mid-shaft section found a rupture in the wire port bond, 24.9cm from the tip of the stent.An attempt was made to inflate the device but due to the hypotube break, it was not possible due to the entry access being closed and the extrusion having ruptured.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent left heart catheterization (lhc).A 2.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon ruptured at 4-6 atmospheres.The stent was then removed undeployed and was still on the stent balloon.The procedure was completed with a different device, and no patient complications were reported.It was further reported that the target lesion was 90% stenosed, non-tortuous and moderate to severely calcified mid and distal left anterior descending artery.The balloon was inflated once, and it ruptured before the stent was even able to be expanded.The device was removed from the body and the stent was still wrapped on the balloon.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16707651
• Report Number: 2124215-2023-16441
• Device Sequence Number: 14356193
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: 08714729985204
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 05/31/2023

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: 11/22/2023
• Device Model Number: H7493941848250
• Device Lot Number: 0028474873
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 05/23/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/16/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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: Unknown