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

Lot Number 0025620260

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent damage occurred.A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However,during procedure, the stent strut was lifted.The procedure was completed with another of the same device and there were no patient complications were reported.

Event Description

It was reported that stent damage occurred.A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However,during procedure, the stent strut was lifted.The procedure was completed with another of the same device and there were no patient complications were reported.It was further reported that the target lesion was severely tortuous and moderately calcified mid right coronary artery.During delivery, resistance was felt and the catheter was not able to cross the lesion.

Manufacturer Narrative

E1: initial reporter city: (b)(6).

Event Description

It was reported that stent damage occurred.A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the stent strut was lifted.The procedure was completed with another of the same device and there were no patient complications were reported.It was further reported that the target lesion was severely tortuous and moderately calcified mid right coronary artery.During delivery, resistance was felt and the catheter was not able to cross the lesion.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr.: a synergy xd mr ous 3.00 x 48mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with mid-section struts pulled proximally.The undamaged 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 identified no issues.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.No issues were noted.No visible issues noted with manifold.No other issues were identified during the product analysis.

• 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: 11041792
• MDR Text Key: 222700273
• Report Number: 2134265-2020-18227
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Lot Number: 0025620260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1