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

Lot Number 0031634169

Device Problems Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/14/2024

Event Type  malfunction  

Event Description

It was reported that an incomplete packaging seal occurred.During preparation of a 4.00 x 48mm synergy xd drug-eluting stent, it was noticed that the stent was already uncoiled at the end when taken out of the packaging.The package was not completely sealed.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by the manufacturer.A synergy xd mr ous 4.00 x 48mm catheter batch was returned for analysis.The device was received without any of its original packaging.A visual and tactile examination identified no kinks or damages.A visual examination of the crimped stent revealed damage at the distal end.A microscopic examination of the hypotube detected no kinks or damages.Microscopic examination of the distal extrusion found no damages.Detailed microscopic examination of the balloon material revealed no damages; the balloon did not appear to have been subjected to any positive pressures.Microscopic examination of the crimped stent detected damage at the distal end, with stent struts at the distal section pulled distally towards the tip section of the device.Microscopic examination of the tip section found no damage.The undamaged crimped stent od (outer diameter) was measured using a snap gauge, which is within the maximum crimped stent profile measurement.

Event Description

It was reported that an incomplete packaging seal occurred.During preparation of a 4.00 x 48mm synergy xd drug-eluting stent, it was noticed that the stent was already uncoiled at the end when taken out of the packaging.The package was not completely sealed.The procedure was completed with another of the same device.No patient complications 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: 18651026
• MDR Text Key: 334766372
• Report Number: 2124215-2024-06465
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031634169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• 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