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

Model Number	H7493941838350
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to cross a lesion, and stent damage occurred.A 3.50 x 38mm synergy xd stent was advanced to the calcified distal right coronary artery (rca), but the stent was not able to cross the distal lesion.The device was removed from the patient, and it was noticed that a stent strut had been pulled back.The procedure was completed with a rota, a 20mm synergy xd was successfully deployed in the distal rca, and ivus ensured stent apposition.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
A 3.50 x 38 mm synergy xd stent delivery system (sds) was returned for analysis.A visual examination of the stent found the stent damage.A strut in the middle of the stent was lifted and pulled in a distal direction.The undamaged stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues noted.The balloon wings were tightly wrapped and folded and were not subjected to positive pressure.A visual examination of the bumper tip showed signs of damage.Examination of the hub and strain relief via scope did not identify any issues.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that failure to cross a lesion and stent damage occurred.A 3.50 x 38mm synergy xd stent was advanced to the calcified distal right coronary artery (rca), but the stent was not able to cross the distal lesion.The device was removed from the patient, and it was noticed that a stent strut had been pulled back.The procedure was completed with a rota, a 20mm synergy xd was successfully deployed in the distal rca, and ivus ensured stent apposition.No patient complications were reported in relation to this event.

• 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: 10588449
• Report Number: 2134265-2020-13222
• Device Sequence Number: 2779235
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 06/08/2022
• Device Model Number: H7493941838350
• Device Lot Number: 0025595421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1