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

Model Number 10622

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that the balloon failed to deflate.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 2.75 x 32mm synergy drug eluting stent was selected for a percutaneous transluminal coronary angioplasty.There was no significant bend involved in the lesion.The lesion pre dilated with a semi compliant balloon.There was no resistance felt advancing the device in the 6 fr guide catheter and over the 0.014 guide wire before deployment of the stent.The synergy was delivered to the lesion site, the balloon inflated once and the stent deployed without any issues.After the stent was implanted, the physician attempted to deflate the balloon for 20 seconds, but the balloon was unable to deflate.The physician attempted to deflate the balloon again for another 20 seconds but it was unsuccessful.The physician then pulled back very hard and the device was successfully removed.The procedure was completed with another stent implanted on top of the first.There were no patient complications reported and the patient was stable post procedure.

Event Description

It was reported that the balloon failed to deflate.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 2.75 x 32mm synergy drug eluting stent was selected for a percutaneous transluminal coronary angioplasty.There was no significant bend involved in the lesion.The lesion pre dilated with a semi compliant balloon.There was no resistance felt advancing the device in the 6 fr guide catheter and over the 0.014 guide wire before deployment of the stent.The synergy was delivered to the lesion site, the balloon inflated once and the stent deployed without any issues.After the stent was implanted, the physician attempted to deflate the balloon for 20 seconds, but the balloon was unable to deflate.The physician attempted to deflate the balloon again for another 20 seconds but it was unsuccessful.The physician then pulled back very hard and the device was successfully removed.The procedure was completed with another stent implanted on top of the first.There were no patient complications reported and the patient was stable post procedure.It was further reported that the distal shaft broke inside of patient.

Manufacturer Narrative

The synergy 2.75 x 32mm stent delivery system (sds) was returned for analysis.The stent, balloon, and tip were not returned.A visual and tactile examination of the hypotube found multiple kinks.A visual examination found a break at the port exchange and a missing distal shaft.The core wire was visible.No other issues were identified during the product analysis.

Event Description

It was reported that the balloon failed to deflate.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A 2.75 x 32mm synergy drug eluting stent was selected for a percutaneous transluminal coronary angioplasty.There was no significant bend involved in the lesion.The lesion pre dilated with a semi compliant balloon.There was no resistance felt advancing the device in the 6 fr guide catheter and over the 0.014 guide wire before deployment of the stent.The synergy was delivered to the lesion site, the balloon inflated once and the stent deployed without any issues.After the stent was implanted, the physician attempted to deflate the balloon for 20 seconds, but the balloon was unable to deflate.The physician attempted to deflate the balloon again for another 20 seconds but it was unsuccessful.The physician then pulled back very hard and the device was successfully removed.The procedure was completed with another stent implanted on top of the first.There were no patient complications reported and the patient was stable post procedure.It was further reported that the distal shaft broke inside of patient.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13766421
• MDR Text Key: 287265903
• Report Number: 2134265-2022-02800
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0026792210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1