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

Model Number	H7493941820250
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage and vessel dissection occurred.The target lesion was located in the left circumflex artery.The lesion was predilated.A 2.50 x 20mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.Physician attempted to remove stent before expanding to administer additional pretreatments.During the stent removal process stent struts got caught in a calcium nodule.Stent successfully removed but became mangled in the process.Additional imaging showed dissection in pretreated artery.The dissection was flow limiting.Additional balloon angioplasty and reattempt to stent resolved all issues.Case was successful and patient recovered well.
Event or Problem Description
It was reported that stent damage and vessel dissection occurred.The target lesion was located in the left circumflex artery.The lesion was predilated.A 2.50 x 20mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.Physician attempted to remove stent before expanding to administer additional pretreatments.During the stent removal process stent struts got caught in a calcium nodule.Stent successfully removed but became mangled in the process.Additional imaging showed dissection in pretreated artery.The dissection was flow limiting.Additional balloon angioplasty and reattempt to stent resolved all issues.Case was successful and patient recovered well.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy xd mr us 2.50 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found mid-section stent damage with struts lifted.The undamaged stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations 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 no issues with the extrusion shaft.No other issues were identified during 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
• MDR Report Key: 12222619
• Report Number: 2134265-2021-09528
• Device Sequence Number: 19763862
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 05/04/2023
• Device Model Number: H7493941820250
• Device Lot Number: 0027301507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 07/24/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention