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

Model Number 10620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 11/23/2020

Event Type  Death  

Event Description

It was reported that a dissection occurred, and the patient expired.Six weeks earlier, a 4.00mm non-boston scientific stent was implanted to treat the 5.75mm in length target lesion located in the left main (lm) artery.The non- boston scientific stent was under expanded measuring only 4.5mm.In (b)(6) 2020, a percutaneous coronary intervention (pci) was performed.A 3.00 x 16 synergy stent was implanted in the left anterior descending artery (lad) without any issues.A 3.00mm x 24mm synergy drug-eluting stent was taken over the non-boston scientific wire and through the previously implanted 4.00mm non-boston scientific stent.The 3.00mm x 24mm synergy stent was deployed at the bifurcation of the lad and left circumflex artery (lcx).A stent boost was taken to see the proximal landing of the expanded synergy stent.At this time the patients pressure dropped and angio revealed a flow limiting dissection distal to the lcx and distal to the deployed stent.The resuscitation team and cardiac surgeon were called to treat the patient.That afternoon, the patient left the catheterization lab in stable condition.It was noted that the physician confirmed that the non-boston scientific wire caused the dissection.However, later that evening the patient passed away.The documented cause of death has not been provided.

Manufacturer Narrative

H6 - patient codes: removed dissection and hypotension codes.

Event Description

It was reported that the patient expired.Six weeks earlier, a 4.00mm non-boston scientific stent was implanted to treat the 5.75mm in length target lesion located in the left main (lm) artery.The non- boston scientific stent was under expanded measuring only 4.5mm.In (b)(6) 2020, a percutaneous coronary intervention (pci) was performed.A 3.00 x 16 synergy stent was implanted in the left anterior descending artery (lad) without any issues.A 3.00mm x 24mm synergy drug-eluting stent was taken over the non-boston scientific wire and through the previously implanted 4.00mm non-boston scientific stent.The 3.00mm x 24mm synergy stent was deployed at the bifurcation of the lad and left circumflex artery (lcx).A stent boost was taken to see the proximal landing of the expanded synergy stent.At this time the patients pressure dropped and angio revealed a flow limiting dissection distal to the lcx and distal to the deployed stent.The resuscitation team and cardiac surgeon were called to treat the patient.That afternoon, the patient left the catheterization lab in stable condition.It was noted that the physician confirmed that the non-boston scientific wire caused the dissection.However, later that evening the patient passed away.The documented cause of death has not been provided.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11002804
• MDR Text Key: 221257373
• Report Number: 2134265-2020-17591
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0025816161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death