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

Model Number	H7493941828270
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered.The 80% stenosed target lesion was located in left anterior descending artery.A 2.75 x 28mm synergy xd drug-eluting stent was deployed, however, the stent delivery system became stuck inside of the stent.A second wire was used to successfully remove the device.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 80% stenosed target lesion was located in left anterior descending artery.A 2.75 x 28mm synergy xd drug-eluting stent was deployed, however, the stent delivery system became stuck inside of the stent.A second wire was used to successfully remove the device.No patient complications were reported.
Additional Manufacturer Narrative
The synergy xd mr us 2.75 x 28mm, stent delivery system was returned for analysis.The balloon was reviewed, and it appeared to be in a deflated state with signs of positive pressure being applied to its cones noted.The stent was deployed from the balloon and was not returned for analysis.A microscopic examination of the balloon material identified no tears or holes.A visual and microscopic examination of the bumper tip showed no issues.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 and a visual examination of the inner lumen found a kink of the shaft polymer extrusion located at the site of the guidewire exchange port.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: 12594541
• Report Number: 2134265-2021-11920
• Device Sequence Number: 4289907
• Product Code: NIQ
• UDI-Device Identifier: 08714729980919
• UDI-Public: 08714729980919
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 03/29/2023
• Device Model Number: H7493941828270
• Device Lot Number: 0027121187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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: Required Intervention
• Patient Sex: Unknown