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

Model Number H7493927408400

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2015

Event Type  Injury  

Event Description

It was reported that during a balloon angioplasty procedure stent migration occurred.The target lesion was located in the left anterior descending artery (lad) and obtuse marginal (om).The om was being treated with plain old balloon angioplasty.The patient began to have increasing amounts of chest pain.Upon further review of the diagnostic angiogram, it was noted that there was a significant ostial left main stenosis, so the decision was made to proceed with stenting of that lesion.With engagement of a non bsc guide, the patient became hemodynamically unstable and began seizing.A non bsc wire was quickly advanced into the lad, and a 4.0 x 8mm rebel stent was deployed into the ostium of the left main with a ¿quick¿ inflation (atm unknown).Due to the patient's condition the physician did not wait until the rebel balloon was fully deflated when removing the stent delivery balloon resulting in the migration of the rebel stent.In subsequent fluoroscopic images, the stent was noted above the aortic valve and then in the descending aorta.The patient continued to become increasingly unstable, and chest compressions were started; however, the patient¿s outcome was fatal.The stent remains inside the patient.In follow up conversations with the physician, he felt the stent embolization into the thoracic/ descending aorta had no impact on the patient outcome.

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4669254
• MDR Text Key: 5732109
• Report Number: 2134265-2015-02108
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2017
• Device Model Number: H7493927408400
• Device Catalogue Number: 39274-0840
• Device Lot Number: 17254463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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
• Treatment: BMW GUIDE WIRE; CORDIS GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 89 YR