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

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 07/29/2022

Event Type  Death  

Event Description

It was reported that the patient died.The straightforward 80-85% target lesion was located in the circumflex to calcified left anterior descending artery (lad) with a diag that had and osteo lesion, that had a 80 degree take off from the lad.A 2.75x15mm emerge balloon, 6f guidezilla ii guide extension catheter, 3.00 x 28mm and 3.0 x 20mm synergy xd stent balloon expandable were selected for use.During the procedure, stenting at the circumflex was performed successfully with the 3.0x28mm stent.The 2.75x15mm balloon was then delivered after repositioning a wire to the 1st diagonal and a wire being placed in the lad from the beginning of the case was established.Multiple inflation was made using the balloon and was removed post injection.Subsequently, the physician called for 3.0x20mm synergy stent, however the patient's pressure was dropping, fluids were then open and there was discomfort from wrist and chest area; pain medications were given.The stent was unable to deliver, thus guidezilla was used and positioned.However, it was unable to reach the full lesion and was pulled back to the guide and a third wire was inserted for the lad.With it across the lesion, the stent was advanced across the diag and the diag wire was removed.The stent was then deployed and removed after multiple inflations.However, post inflation showed timi 1/2 flow to the diag.With this, the diag was tried to wire with one of the wires from the lad.Multiple attempts were made to wire diag., but the flow to lad was affected while these attempts were made, thus a 2.75 x 12mm nc balloon was delivered to lad.Timi 3 flow was back after multiple inflations were made.Consequently, the unsuccessful multiple attempts made to wire the diag was stopped and the wire was pulled.Injection to the groin and a closing device was asked for.After 10-20 mins pass, a code was called to the lab of the intervention wherein, intubation and cpr were administered.However, the patient expired.

Manufacturer Narrative

F10- updated device codes.

Event Description

It was reported that the patient died.The straightforward 80-85% target lesion was located in the circumflex to calcified left anterior descending artery (lad) with a diag that had and osteo lesion, that had a 80 degree take off from the lad.A 2.75x15mm emerge balloon, 6f guidezilla ii guide extension catheter, 3.00 x 28mm and 3.0 x 20mm synergy xd stent balloon expandable were selected for use.During the procedure, stenting at the circumflex was performed successfully with the 3.0x28mm stent.The 2.75x15mm balloon was then delivered after repositioning a wire to the 1st diagonal and a wire being placed in the lad from the beginning of the case was established.Multiple inflation was made using the balloon and was removed post injection.Subsequently, the physician called for 3.0x20mm synergy stent, however the patient's pressure was dropping, fluids were then open and there was discomfort from wrist and chest area; pain medications were given.The stent was unable to deliver, thus guidezilla was used and positioned.However, it was unable to reach the full lesion and was pulled back to the guide and a third wire was inserted for the lad.With it across the lesion, the stent was advanced across the diag and the diag wire was removed.The stent was then deployed and removed after multiple inflations.However, post inflation showed timi 1/2 flow to the diag.With this, the diag was tried to wire with one of the wires from the lad.Multiple attempts were made to wire diag., but the flow to lad was affected while these attempts were made, thus a 2.75 x 12mm nc balloon was delivered to lad.Timi 3 flow was back after multiple inflations were made.Consequently, the unsuccessful multiple attempts made to wire the diag was stopped and the wire was pulled.Injection to the groin and a closing device was asked for.After 10-20 mins pass, a code was called to the lab of the intervention wherein, intubation and cpr were administered.However, the patient expired.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15258679
• MDR Text Key: 298216378
• Report Number: 2134265-2022-08577
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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
• Date Manufacturer Received: 08/24/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White