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

Model Number	H7493941832500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear occurred.A 5.00 x 32mm synergy xd drug-eluting stent was used, however; it was noted that the balloon was torn off from the catheter.No patient complications were reported.
Event or Problem Description
It was reported that balloon tear occurred.A 5.00 x 32mm synergy xd drug-eluting stent was used, however; it was noted that the balloon was torn off from the catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 5.00 x 32 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no stent on the sds.The crimped stent outer diameter at the time of manufacturing is 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.The balloon body was covered in brownish medium resembling blood.There was no sign of damage noted on the balloon.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a shaft polymer extrusion break at the port bond.The shaft polymer extrusion was stretched around the break site and was covered with brownish medium resembling blood.The device was placed in water-bath to soften the hardened media.The device was placed in water-bath to soften the hardened media.The returned device was attached to an inflation unit and positive pressure was applied to rated burst pressure to inflate the balloon and the balloon inflated with no issues.No leaks or damage to the balloon observed.The inflation device was verified for functionality at to rated burst pressure before and after use with pressure tester.No other issues were identified during analysis.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11740757
• Report Number: 2134265-2021-05156
• Device Sequence Number: 14514279
• Product Code: NIQ
• UDI-Device Identifier: 08714729981299
• UDI-Public: 08714729981299
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 06/24/2022
• Device Model Number: H7493941832500
• Device Lot Number: 0025663506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1