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

Model Number H7493941820400

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 4.0 x 20mm synergy xd drug-eluting stent was advanced.However, the stent got caught on the proximal end of the 3.5 x 38mm synergy drug-eluting stent.The 4.0 x 20mm synergy xdwas removed and noticed the end of the stent was damaged.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr us 4.00 x 20mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent identified stent damage.Stent damage in the mid to distal stent region with struts lifted and pulled proximally.The undamaged stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.An examination (visual and via scope) found no issues with the tip.No other device issues were noted during analysis.

Event Description

It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 4.0 x 20mm synergy drug-eluting stent was advanced.However, the stent got caught on the proximal end of the 3.5 x 38mm synergy drug-eluting stent.The 4.0 x 20mm synergy was removed and noticed the end of the stent was damaged.The procedure was completed with another of the same device.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: 11007886
• MDR Text Key: 221550153
• Report Number: 2134265-2020-17727
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• 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
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: H7493941820400
• Device Lot Number: 0025937678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1