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

Model Number H7493941824500

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Defective Device (2588); Difficult to Advance (2920)

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

Event Date 02/18/2021

Event Type  malfunction  

Event Description

It was reported that difficulty removal were encountered.The target lesion was located in the right coronary artery (rca).A 5.00 x 24mm synergy xd drug eluting stent was selected for use.The synergy xd drug eluting stent was advanced but could not cross the lesion.Upon removal the synergy xd drug eluting stent, the stent was catching on the catheter.It was observed that the balloon was slightly inflated on each end of the stent.The procedure was completed with a non-bsc stent.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr ous 5.00 x 24 mm stent delivery system was returned for analysis.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 by snap gauge 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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.

Event Description

It was reported that difficulty removal were encountered.The target lesion was located in the right coronary artery (rca).A 5.00 x 24mm synergy xd drug eluting stent was selected for use.The synergy xd drug eluting stent was advanced but could not cross the lesion.Upon removal the synergy xd drug eluting stent, the stent was catching on the catheter.It was observed that the balloon was slightly inflated on each end of the stent.The procedure was completed with a non-bsc stent.No patient complications were reported.

• 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: 11474135
• MDR Text Key: 239446302
• Report Number: 2134265-2021-02712
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981275
• UDI-Public: 08714729981275
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: H7493941824500
• Device Lot Number: 0026382640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR