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

Lot Number	0031919961
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.Using a cls3.5 guide catheter, a luge wire was placed in the left circumflex artery (lcx).Angioplasty was performed with a 2.5 x 12 balloon with multiple inflations from 6 atmospheres (atm) up to 14 atm.A samurai wire was also placed in the left anterior descending artery as a precaution.A 2.25 x 38 synergy drug-eluting stent (des) was deployed at 16 atm for 20 seconds; and another unspecified 2.50 x 20 stent was deployed into the left main in the lcx at 18 atm for 20 seconds.Post-deployment, angiogram was performed which showed that there was a gap between two stents.A 2.25 x 16mm synergy xd des was then advanced but failed to cross the lesion and was damaged, so the stent was removed.A 2.25 x 12mm synergy xd des was also advanced but still failed to cross the lesion.A non-boston scientific (non-bsc) guide extension catheter was then introduced; but as the 2.25 x 12mm stent was removed, it was noted that the stent was left in the lcx area.Since stent was still on the wire, a 1.20 balloon was advanced and inflated distal to the stent to try to bring the stent into the guide, and then a 1.50 balloon, but both were unsuccessful.A 2.50 emerge balloon catheter was partially inflated distal to the stent and partially in the guide to remove everything.However, at the edge of the sheath the stent became disconnected from the system and moved into the profunda.Since access was still maintained with the samurai wire, the stenting procedure was able to be completed by putting the cl 3.5 guide catheter back in the artery and re-wiring the artery.The non-bsc guide extension catheter was used to advance a balloon for pre-dilation and then a stent which was successfully deployed.Repeat angiogram revealed full expansion of the stents, and timi 3 flow in the remnants of the lad and lcx.A vascular surgeon was called to help remove the stent from artery in a separate procedure.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19498783
• Report Number: 2124215-2024-31964
• Device Sequence Number: 7926067
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 06/20/2025
• Device Lot Number: 0031919961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Date Device Manufactured: 06/21/2023
• 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