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

Model Number	H7493941820220
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% occluded target lesion was located in the moderately tortuous and moderately calcified proximal diagonal artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when attempted to pull negative on balloon, the blood goes back in and found the balloon was burst after removal.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 20mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no evidence of any damage.The crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.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 microscopic examination of the balloon area identified no tears or holes in the balloon material.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.A visual examination of the outer and inner lumen and mid-shaft section found a shaft break at 35 cm proximal to the distal end of the tip in the lasercut region, in the midshaft extrusion.The device was soaked in a water bath at 37 degrees celsius in order to soften any solidified media inside the device.A 0.014inch guidewire was inserted through the tip and wire lumen with no restrictions noted.An attempt to inflate the balloon to its rated burst pressure (rbp) of 18 atmospheres (atm) identified a leak at the break in the extrusion at the lasercut region.The device was cut at the break site and an inflation aid was used to facilitate the inflation of the balloon.Using an encore inflation device, the balloon was inflated to rbp, held pressure and deflated in 8 seconds and the stent deployed without issues.The encore device was verified before and after use using the druck gauge to 18 atm.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% occluded target lesion was located in the moderately tortuous and moderately calcified proximal diagonal artery.A 2.25 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when attempted to pull negative on balloon, the blood goes back in and found the balloon was burst after removal.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12757793
• Report Number: 2134265-2021-13931
• Device Sequence Number: 19871588
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: 08714729980735
• 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,Followup
• Report Date (Section B): 12/15/2021

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: 04/06/2023
• Device Model Number: H7493941820220
• Device Lot Number: 0027142016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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