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

Lot Number 0025951499

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a foreign matter was present in the device.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left coronary artery.A 2.25 x 28mm synergy xd drug eluting stent was introduced but the device could not advance in the guiding catheter.The device was removed and when checked visually, a lump of iron-like material was found.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter city: (b)(6).Device evaluated by mfr.: synergy xd 2.25 x 28mm 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 (od) 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.Mid shaft bond od was measured.The mid-shaft bond measurement did not meet specification requirements.No kinks or damage was noted.A 0.014 inch guide wire was loaded into a test 5f guide catheter.The complaint device was loaded onto the guide wire and inserted into the 5f guide catheter however the device could not pass into the guide catheter due to the mid shaft bond.No other issues were noted during product analysis.

Event Description

It was reported that a foreign matter was present in the device.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left coronary artery.A 2.25 x 28mm synergy xd drug eluting stent was introduced but the device could not advance in the guiding catheter.The device was removed and when checked visually, a lump of iron-like material was found.The procedure was completed with a different device.There were no patient complications 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: 11440178
• MDR Text Key: 238627248
• Report Number: 2134265-2021-02269
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2022
• Device Lot Number: 0025951499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1