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

Model Number 10618

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

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

Event Date 10/10/2021

Event Type  malfunction  

Event Description

It wa reported that difficulty removal and deflation failure occurred.The target lesion was located in the left anterior descending artery.A 4.50 x 16mm synergy ii drug eluting stent was advanced for treatment.After the stent was deployed in the lesion, the doctor tried to remove the stent balloon but it could not come out of the guiding catheter.The balloon was deflated for about 30 seconds a vacuum was held during removal after the stent would not deflate and was removed partially inflated.The physician remove the guiding catheter, wire and balloon as one unit to get everything out safely and completed the procedure with the same device.There were no patient complications reported.

Event Description

It wa reported that difficulty removal and deflation failure occurred.The target lesion was located in the left anterior descending artery.A 4.50 x 16mm synergy ii drug eluting stent was advanced for treatment.After the stent was deployed in the lesion, the doctor tried to remove the stent balloon but could not come out of the guiding catheter after the stent would not deflate.So the physician remove the guiding catheter wire and balloon as one unit to get everything out safely and completed the procedure with the same device.There were no patient complications reported.It was further reported that the target lesion was 100% stenosed and was mildly tortuous and mildly calcified.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12650334
• MDR Text Key: 277132625
• Report Number: 2134265-2021-13042
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150003/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0025228873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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