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

Model Number H7493941812350

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was selected for use.However, the delivery system broke after removing from the package.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was used, however; the device broke after removing from the package.The procedure was completed with different device and no patient complications were reported.Previously, it was reported that the shaft broke.Now, it is confirmed that the tip of the hypotube was bent occurred.

Manufacturer Narrative

Device evaluated by mfr.: a synergy xd mr us 3.50 x 12mm stent delivery system was returned for analysis with a haemostatic valve attached.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks and a break 68.6cm distal to the distal end of the strain relief.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.A kink was noted at the wire exchange port.No other issues were identified during the product analysis.

Manufacturer Narrative

H6 - device codes corrected from break 1069 to material deformation 2976.

Event Description

It was reported that shaft break occurred.A 3.50 x 12mm synergy xd drug-eluting stent was selected for use.However, the delivery system broke after removing from the package.The procedure was completed with a different device.No patient complications were reported.Previously, it was reported that the shaft broke.Now, it is confirmed that the tip of the hypotube was just bent and not fractured.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11164355
• MDR Text Key: 226632587
• Report Number: 2134265-2020-18891
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: H7493941812350
• Device Lot Number: 0026135304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1