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

Lot Number 0031089004

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that an entrapment on the guidewire occurred.A 3.50 x 48mm synergy stent was advanced for a percutaneous coronary intervention.However, the device was joint together with the wire and would not come off, therefore was stuck.No further information on the outcome of this event.

Event Description

It was reported that an entrapment on the guidewire occurred.A 3.50 x 48mm synergy stent was advanced for a percutaneous coronary intervention.However, the device was joint together with the wire and would not come off, therefore was stuck.No further information on the outcome of this event.

Manufacturer Narrative

The 3.50 x 48mm synergy stent was returned for analysis.Visual, tactile, microscopic and device to device interaction testing was performed.A visual and tactile examination of the hypotube shaft profile identified no damage.The device was received in two sections as a result of a break in the distal extrusion.The break was located at 4mm distal to the guidewire exit port.The distal section of the shaft extrusion break was severely stretched and bunched/accordioned.As a result of the stretching, the inner/wire lumen was stretched down onto the guidewire, preventing this section of the device from being removed from the wire.A microscopic examination of the distal extrusion, at the break location, confirmed that the shaft was stretched at the break site.The distal section of the shaft extrusion break was severely stretched and bunched/accordioned.A microscopic examination of the crimped stent identified that the stent was damaged with evidence that the stent was stretched on the balloon.A microscopic examination of the balloon identified no damage.Device to device interaction testing revealed the distal section of the shaft extrusion break was severely stretched and bunched/accordioned.As a result of this damage the extrusion was severely stretched down onto the guidewire used during the procedure.Attempts to remove the guidewire failed.

• Brand Name: SYNERGY XD
• Type of Device: 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: 18089405
• MDR Text Key: 327612526
• Report Number: 2124215-2023-62380
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: 08714729985235
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031089004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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