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

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

Patient Problem Restenosis (4576)

Event Date 11/11/2022

Event Type  Death  

Event Description

It was reported that the patient died.In (b)(6) 2021, an index procedure was performed and implanted two synergy xd drug-eluting stents (des) and two synergy megatron des in the ostial left main artery (lm), ostial to proximal circumflex artery (cx), mid left anterior descending artery (lad), and ostial to proximal first diagonal artery (diag1).A chronic total occlusion was documented in the right coronary artery (rca).In (b)(6) 2022, the physician attempted to treat the restenosis found in the ostial cx.It was believed that the stents implanted in the ostial cx and lm were not fully expanded during the index procedure which led to the unintentional passing of guidewires through these unopposed stent struts.A 2.00 x 15mm emerge balloon catheter was advanced to the lm and into the cx where it was inflated to 10 atmospheres (atm), but the balloon ruptured.The physician attempted to remove the 2.00 x 15mm emerge but a significant resistance was encountered.The balloon got stuck in the vessel and when an extreme force was applied to remove the device, the distal half of the balloon fractured and remained stuck in the lm and cx.In order to trap and recover the distal shaft of the fractured device, a 2.00 x 15mm nc emerge balloon catheter was advanced into the lad and inflated to 16 atm.While withdrawing the inflated nc emerge balloon which was initially dragging the detached component of emerge balloon, the distal shaft of the nc emerge also fractured and was stuck in the lad.A non-bsc catheter-based miniaturized ventricular assist device was inserted to stabilize the patient but failed to sustain.Subsequently, the patient expired.

Manufacturer Narrative

(b)(6).

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15837723
• MDR Text Key: 304079143
• Report Number: 2124215-2022-47852
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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
• Report Date: 11/21/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 82 YR
• Patient Sex: Male