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

Model Number	H7493941820250
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a 2.50 x 20 mm synergy xd stent delivery system (sds) was returned for analysis.Examination of the crimped stent via scope found damage to the stent with the most proximal and most distal stent strut rows lifted from the crimped position.The undamaged crimped stent outer diameter was measured and the result 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.Blood like substance was noted in the balloon.The hub was examined via scope and no issues were noted.A visual and tactile examination of the hypotube identified a kink and partial break in hypotube laser cut region at 23 mm distal of the hypotube mid shaft bond with the device still intact.Multiple hypotube kinks were also noted.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on analysis completed on 16dec2020.It was reported that a kink occurred.A percutaneous coronary intervention was performed on a patient with coronary artery disease (cad).The 90% stenosed target lesion was located in the mildly calcified and mildly tortuous distal left anterior descending artery (lad).A 2.50 x 20mm synergy xd stent was opened and prepped accordingly.The synergy stent was inserted into the touhy and the delivery system was then advanced, but the delivery system shaft kinked immediately.The kink occurred mid to distal on the shaft.It was noted that the device was in the guide catheter, and not the patient's artery.No resistance was felt while advancing.The device was removed intact and the procedure was successfully completed with another of the same device.No patient complications resulted in relation to this event.However, the device returned and analysis revealed stent damage.

• 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: 11064858
• Report Number: 2134265-2020-18219
• Device Sequence Number: 11415686
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 12/23/2020

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: H7493941820250
• Device Lot Number: 0025602888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1