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

Model Number	H7493941816270
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in mildly tortuous and severely calcified left anterior descending artery.The physician tried to advance the 2.75 x 16mm synergy xd stent through a previously deployed stent in order to rescue a side branch which had been pinched.The balloon was never inflated but the stent moved on the balloon and became dislodged.An attempt to snare the stent was not successful.The stent delivery system (sds) was difficult to remove and had to be removed together with the guidewire.Once outside the patient, the guidewire was able to be removed from the sds.The sds was noted to be stretched.No other device was used to complete the procedure.There were no patient complications.The dislodged stent is scheduled to be removed on (b)(6).
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in mildly tortuous and severely calcified left anterior descending artery.The physician tried to advance the 2.75 x 16mm synergy xd stent through a previously deployed stent in order to rescue a side branch which had been pinched.The balloon was never inflated but the stent moved on the balloon and became dislodged.An attempt to snare the stent was not successful.The stent delivery system (sds) was difficult to remove and had to be removed together with the guidewire.Once outside the patient, the guidewire was able to be removed from the sds.The sds was noted to be stretched.No other device was used to complete the procedure.There were no patient complications.The dislodged stent is scheduled to be removed on december 30th.It was further reported that the stent dislodged from the balloon at the proximal left anterior descending artery back to left main coronary artery.On november 30th, the device was successfully snared at another hospital with no surgery required.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in mildly tortuous and severely calcified left anterior descending artery.The physician tried to advance the 2.75 x 16mm synergy xd stent through a previously deployed stent in order to rescue a side branch which had been pinched.The balloon was never inflated but the stent moved on the balloon and became dislodged.An attempt to snare the stent was not successful.The stent delivery system (sds) was difficult to remove and had to be removed together with the guidewire.Once outside the patient, the guidewire was able to be removed from the sds.The sds was noted to be stretched.No other device was used to complete the procedure.There were no patient complications.The dislodged stent is scheduled to be removed on (b)(6).It was further reported that the stent dislodged from the balloon at the proximal left anterior descending artery back to left main coronary artery.On (b)(6), the device was successfully snared at another hospital with no surgery required.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd 2.75 x 16mm stent delivery system catheter was returned for analysis.There was no stent returned.The balloon cones were reviewed, and there were no signs of positive pressure applied.Crimp markings were evident on exposed balloon wall.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 along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found 9cm section of stretching starting at 12 cm proximal to distal tip.No other issues were noted.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15946007
• Report Number: 2124215-2022-50830
• Device Sequence Number: 20388365
• Product Code: NIQ
• UDI-Device Identifier: 08714729980889
• UDI-Public: 08714729980889
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: H7493941816270
• Device Lot Number: 0028266143
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/13/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/03/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White