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

Model Number H7493941820250

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Chest Pain (1776); Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was reported that removal difficulties were encountered which led to patient complications and a shaft break.The patient presented not doing well and already in cardiac shock.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified obtuse marginal (om) branch.The physician had to stent the lesion proximal to distal.The second stent, a 2.50 x 20mm synergy xd, was deployed to an unknown pressure below rated burst pressure.Post stent deployment, the stent delivery system (sds) balloon would not deflate and was stuck in the artery.More than 10 minutes was spent trying to deflate the balloon and while the balloon remained inflated, the patient experienced chest pain and coded.Multiple stiff wires and snares were used in an attempt to pop the balloon.When these attempts were unsuccessful, the wire and sds were pulled, but both the wire and sds shaft snapped; the sds shaft broke right before the proximal markerband.The wire fragments were able to be snared but some of the sds remained inside the patient causing the om branch to occlude.Because the patient had presented for the procedure already in cardiac shock, surgery to remove the device fragment was not an option.Additional information was requested on the patient outcome.

• Brand Name: SYNERGY XD
• Type of Device: 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13999379
• MDR Text Key: 288597322
• Report Number: 2134265-2022-03184
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: 08714729980810
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: H7493941820250
• Device Lot Number: 0027535510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention