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

Model Number	H7493941812350
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that stent damage occurred.Following pre-dilatation, a 3.50 x 12mm synergy xd drug eluting stent was advanced for treatment.However, resistance was felt during advancing and it failed to cross the guide catheter.Upon removal, it was noted that a strut was sticking up at the distal edge of the stent.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that stent damage occurred.Following pre-dilatation, a 3.50 x 12mm synergy xd drug eluting stent was advanced for treatment.However, resistance was felt during advancing and it failed to cross the guide catheter.Upon removal, it was noted that a strut was sticking up at the distal edge of the stent.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Updated d4: lot number as per ga 14979615.E1: initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).Device evaluation by mfr: the synergy xd mr us 3.50 x 12mm mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with stent struts from the mid stent region lifted and pulled proximally.The undamaged crimped stent od (outer diameter) was measured by snap gauge and was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and microscopic examination of the bumper tip no issues.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.The device could be loaded on a test guidewire without issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.Following pre-dilatation, a 3.50 x 12mm synergy xd drug eluting stent was advanced for treatment.However, resistance was felt during advancing and it failed to cross the guide catheter.Upon removal, it was noted that a strut was sticking up at the distal edge of the stent.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: 13839160
• Report Number: 2134265-2022-03167
• Device Sequence Number: 13703090
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• 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,Followup
• Report Date (Section B): 04/19/2022

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: 10/18/2023
• Device Model Number: H7493941812350
• Device Lot Number: 0028300291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 04/14/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/11/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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