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

Lot Number 0026625374

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 08/06/2021

Event Type  malfunction  

Event Description

It was reported that balloon deflation failure occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.50 x 20mm synergy xd drug-eluting stent was successfully directly deployed at 20 atmospheres for overexpansion.However, during deflation, the tip of the stent delivery system (sds) balloon did not fully deflate.The deflated part of the balloon was stuck on the guiding catheter and the physician had to remove the wire and the catheter to bring out the sds.No patient complications nor injuries were reported and the patient status was stable.

Manufacturer Narrative

The synergy xd mr ous 3.50 x 20mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no stent on the sds.The crimped stent outer diameter (od) at the time of manufacturing was within maximum crimped stent profile measurement.The balloon was returned in a deflated state.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 on several locations of the hypotube shaft.A visual and tactile examination identified no issues.The device was placed in water-bath to soften the hardened media.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied.The balloon inflated and held pressure and deflated without issues.The device tracked through a 0.014 guidewire without issue.

Event Description

It was reported that balloon deflation failure occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.50 x 20mm synergy xd drug-eluting stent was successfully directly deployed at 20 atmospheres for overexpansion.However, during deflation, the tip of the stent delivery system (sds) balloon did not fully deflate.The deflated part of the balloon was stuck on the guiding catheter and the physician had to remove the wire and the catheter to bring out the sds.No patient complications nor injuries were reported and the patient status was stable.

• 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: 12318488
• MDR Text Key: 266398573
• Report Number: 2134265-2021-10384
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Lot Number: 0026625374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR