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

Model Number 10617

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Migration (4003)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that stent was not visible after implanted.The target lesion was located in the ostial right coronary artery.A 2.75 x 12 synergy ii drug-eluting stent was advanced and deployed for treatment.Post-dilation was performed with 3.0x8mm nc balloon; however, the stent was not visible when the wire was removed and picture was taken.The physician proceeded to re wire and another 3.0 x 8mm synergy stent was deployed and post dilated.After that, a full body scan was performed with no sign of the stent.The procedure was completed with a different 3.0x8mm synergy stent.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

H2: ar code correction.

Event Description

It was reported that stent was not visible after implanted.The target lesion was located in the ostial right coronary artery.A 2.75 x 12 synergy ii drug-eluting stent was advanced and deployed for treatment.A post-dilation was performed with 3.0x8mm nc balloon; however, the stent was not visible when the wire was removed and picture was taken.The physician proceeded to re wire and another 3.0 x 8mm synergy stent was deployed and post dilated with a 3.0 x 8 mm nc balloon.After that, a full body scan was performed with no sign of the stent.The procedure was completed with a different 3.0x8mm synergy stent.No patient complications were reported and the patient status was stable.It was further reported that the second stent, a 3.0 x 8mm synergy des, was successfullydeployed and visible on cine.The 2.75x12mm synergy des was not visible as it potentially migrated upon inflation.The staff confirmed all materials used were checked and a stent was nowhere to be found.

Event Description

It was reported that stent was not visible after implanted.The target lesion was located in the ostial right coronary artery.A 2.75 x 12 synergy ii drug-eluting stent was advanced and deployed for treatment.A post-dilation was performed with 3.0x8mm nc balloon; however, the stent was not visible when the wire was removed and picture was taken.The physician proceeded to re wire and another 3.0 x 8mm synergy stent was deployed and post dilated with a 3.0 x 8 mm nc balloon.After that, a full body scan was performed with no sign of the stent.The procedure was completed with a different 3.0x8mm synergy stent.No patient complications were reported and the patient status was stable.It was further reported that the second stent a 3.0 x 8mm synergy stent was deployed as the initial stent went missing upon inflation.Furthermore, the 2.75x12mm synergy stent was not visible as it perhaps traveled inside the patient or may have also been pulled back in the guide catheter.The staff confirmed they checked all materials used and stent was nowhere to be found.

• 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: 13686443
• MDR Text Key: 286774610
• Report Number: 2134265-2022-02511
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0027561669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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