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

Lot Number 0026948604

Device Problems Obstruction of Flow (2423); Activation Failure (3270)

Patient Problems Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440)

Event Date 11/28/2021

Event Type  Injury  

Event Description

It was reported that insufficient apposition, st elevation, and stent thrombosis occurred.The patient had a heart attack and was admitted as an emergency case.The non-totally occluded target lesion was located in the non-calcified ostial left anterior descending artery (lad) to left main (lm).The 3.50 x 32mm synergy megatron stent was implanted in the target lesion up to 12 atmospheres.Intravascular ultrasound (ivus) revealed the distal part of the megatron stent was underexpanded and some plaque was not covered.A 3.00 x 32 synergy xd stent was implanted overlapping the megatron at the ostial lad to proximal lad.The overlapping section was post dilated with a 4.00 x 15mm non-boston scientific balloon.When the stent was checked with angiography, underexpansion was noticed.Post dilation was performed again with a 4.00 x 8mm nc emerge balloon.Ivus was then performed which revealed a gap between the megatron and the synergy xd despite multiple post-dilations.The physician reviewed the ivus and measured the msa at the underexpanded overlapping section at 7.56mm^2.Angiography showed good flow with no thrombus so the procedure was considered successful and the patient sent back to the ward.Twenty-four hours later, the patient returned with st elevation and stent thrombosis was diagnosed.Optical coherence tomography (oct) showed a stent gap of 0.39mm, malapposition between overlapping stents.The clots were aspirated and the patient is now stable but the physician intends to bring the patient back for a staged procedure to correct the malapposition.

Manufacturer Narrative

Age at time of event: 18 years or older.

Manufacturer Narrative

A2: age at time of event: 18 years or older.

Event Description

It was reported that insufficient apposition, st elevation, and stent thrombosis occurred.The patient had a heart attack and was admitted as an emergency case.The non-totally occluded target lesion was located in the non-calcified ostial left anterior descending artery (lad) to left main (lm).The 3.50 x 32mm synergy megatron stent was implanted in the target lesion up to 12 atmospheres.Intravascular ultrasound (ivus) revealed the distal part of the megatron stent was underexpanded and some plaque was not covered.A 3.00 x 32 synergy xd stent was implanted overlapping the megatron at the ostial lad to proximal lad.The overlapping section was post dilated with a 4.00 x 15mm non-boston scientific balloon.When the stent was checked with angiography, underexpansion was noticed.Post dilation was performed again with a 4.00 x 8mm nc emerge balloon.Ivus was then performed which revealed a gap between the megatron and the synergy xd despite multiple post-dilations.The physician reviewed the ivus and measured the msa at the underexpanded overlapping section at 7.56mm^2.Angiography showed good flow with no thrombus so the procedure was considered successful and the patient sent back to the ward.Twenty-four hours later, the patient returned with st elevation and stent thrombosis was diagnosed.Optical coherence tomography (oct) showed a stent gap of 0.39mm, malapposition between overlapping stents.The clots were aspirated and the patient is now stable but the physician intends to bring the patient back for a staged procedure to correct the malapposition.It was further reported that the target lesion was 50% stenosed and non-tortuous.The planned staged procedure to correct the malapposition has not yet been performed.

• Brand Name: SYNERGY XD
• 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: 12929107
• MDR Text Key: 282101390
• Report Number: 2134265-2021-15313
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SN
• 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
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Lot Number: 0026948604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Patient Outcome(s): Required Intervention; Other