MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE REBEL; STENT, CORONARY

Model Number UNK787

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Intimal Dissection (1333); Death (1802); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 08/17/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).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

It was reported that heart attack, in-stent restenosis, no flow, vessel dissection, stent explant, myocardial infarction occurred and the patient died.The target lesion was located in a circumflex artery.A 3.5x16 rebel stent was successfully deployed.However, hours later, the patient presented with heart attack and was taken to the intensive care unit (icu) back to the catheter laboratory.The second physician noted that the implanted stent had completely closed up and restenosis occurred and thus there was no flow through the stent.The physician opened up the rebel and placed another stent.When the physician did that, the rebel got caught with the guide wire and when he went to pull it back, the rebel got dislodged and then it became stuck in the aorta.The physician unintentionally dissected the circumflex artery and then he had to retrieve the rebel stent with a snare.The procedure was completed and the patient left the catheter laboratory.However, a couple of hours later, it was further reported that the patient fell off a roof and died.The cause of death was myocardial infarction.No autopsy was performed.

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• 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: 6854235
• MDR Text Key: 85587398
• Report Number: 2134265-2017-08980
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• 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; Required Intervention
• Patient Age: 76 YR