MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number UNK731

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

Patient Problem Death (1802)

Event Date 06/20/2018

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-06130.It was reported that patient death occurred.The patient presented with in-stent restenosis of a non-bsc stent.The target lesion was located in the proximal circumflex artery.A non-bsc guide catheter was advanced and a non-bsc guidewire passed through the stent.An emerge balloon was inflated to nominal pressure inside the restenosed stent and removed.A synergy¿ drug-eluting stent was then deployed successfully inside the restenosed stent, and the stent delivery system was removed from the artery and taken out of the body.The physician injected contrast through the guide catheter and the image showed possible thrombus filling into the circumflex and left anterior descending artery and out to the left main.The synergy¿ drug-eluting stent was fully patent, it did not show any sign of thrombus within the stent.At this point, a dissection proximal to the deployed synergy¿ drug-eluting stent was also a possibility.The rest of the procedure lasted for approximately 40 minutes during which time every attempt was made to extract the thrombus.The patient passed away on the table.The cause of death was sub therapeutic heparin with tissue in the heparin line present.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7639392
• MDR Text Key: 112382340
• Report Number: 2134265-2018-06131
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• 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: 54 YR