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

Model Number	H7493941828270
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The >70% stenosed target lesion was located in the mildly tortuous and mildly calcified in obtuse marginal artery.Following pre-dilation, a 2.75 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the device would not cross the lesion.The physician pulled the stent back out and it was noticed that the stent was damaged and looked like it got caught on something and "unraveled." the device was removed and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.The >70% stenosed target lesion was located in the mildly tortuous and mildly calcified in obtuse marginal artery.Following pre-dilation, a 2.75 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, the device would not cross the lesion.The physician pulled the stent back out and it was noticed that the stent was damaged and looked like it got caught on something and unraveled.The device was removed and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: the synergy xd mr ous 2.75 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the strut damaged in the mid section of the stent.The device was returned with a second stent caught in the crimped stent that was expanded and streched.The undamaged crimped stent od (outer diameter) was measured using a snap gauge and was within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product 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
• 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: 13318334
• Report Number: 2134265-2022-00539
• Device Sequence Number: 5022877
• Product Code: NIQ
• UDI-Device Identifier: 08714729980919
• UDI-Public: 08714729980919
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 07/23/2023
• Device Model Number: H7493941828270
• Device Lot Number: 0027806327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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 Age: 54 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG