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

Lot Number 0030271976

Device Problem Leak/Splash (1354)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that a shaft hole occurred.A 2.25 x 16mm synergy drug-eluting stent (des) was selected for treatment.However, during preparation, it was noted that a contrast was leaking from the midshaft which would not allow the stent to be prepped appropriately.The procedure was completed with a different device.There were no patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: synergy xd mr us 2.25 x 16mm was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.No issues identified with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a cut, 1cm proximal to the port exchange.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation unit and an attempt was made to inflate the device.However, a leak was observed at the cut on the outer polymer extrusion near the port exchange.

Event Description

It was reported that a shaft hole occurred.A 2.25 x 16mm synergy drug-eluting stent (des) was selected for treatment.However, during preparation, it was noted that a contrast was leaking from the midshaft which would not allow the stent to be prepped appropriately.The procedure was completed with a different device.There were no patient complications were reported.

• 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: 17685706
• MDR Text Key: 322669382
• Report Number: 2124215-2023-44749
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: 08714729980728
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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
• Device Operator: Health Professional
• Device Lot Number: 0030271976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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