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

Model Number H7493927324350

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  Injury  

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 stent fracture occurred.Vascular access was obtained via the radial artery.The 100% stenosed, 24mm x 3.5-4.0mm and the de novo target lesion was located in the non-tortuous and mildly calcified left circumflex artery (lcx) to the oblique marginal artery (om).A 3.5x6mm non-bsc guide catheter was engaged in the left main trunk and a 0.014" non-bsc guide wire was advanced to the distal om.Predilation was performed with a 2.0x12mm and a 3.0x20mm balloon catheters.A 24 x 3.50mm rebel stent was implanted in the lesion and a 4.0x8mm non-bsc balloon was used to post dilate the stent but it was noted that the stent struts totally broke off.A 4.5x12mm rebel stent was placed in the proximal segment of the previously implanted stent with good end result and timi 3 distal run off and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• 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: 7715857
• MDR Text Key: 114887814
• Report Number: 2134265-2018-06597
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: H7493927324350
• Device Catalogue Number: 39273-2435
• Device Lot Number: 21920009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 78