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

Model Number H7493927320350

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mf: it is indicated that the device will not be returned for evaluation.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).

Event Description

Same case as mdr id 2134265-2015-08120 and 2134265-2015-08121.It was reported that insufficient stent apposition and stent damage occurred.The target lesion was located in the right coronary artery (rca).A 20 x 2.50mm rebel stent was selected however; the device was caught and damaged during insertion.The 24 x 3.50mm rebel stent was then advanced and deployed in the proximal rca.A 24 x 2.50mm rebel stent was then advanced to the distal rca.The physician wanted to remove the device so they could further balloon the distal vessel.Upon removal of the 24 x 2.50mm rebel stent it caught on the proximal 24 x 3.50mm rebel stent that had already been deployed.The stent was removed and was found to be crushed.The implanted 24 x 3.50mm rebel stent was also noted to be malformed.Three days later, the patient was brought back to the cardiac catheterization laboratory and a 2.75 x 20mm rebel stent was deployed in the distal rca using a non-bsc guide extension catheter.The previously implanted 24 x 3.50mm rebel stent was re-ballooned.No patient complications were reported and the patient's status was stable.Upon case review of the optical coherence tomography (oct) images of the initial procedure, it was noted that the implanted 24 x 3.50mm rebel stent was not fully apposed and was hanging mid vessel, which may have contributed to the 24 x 2.50mm rebel stent getting caught as they were attempting to place it.

• 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: 5257518
• MDR Text Key: 32386154
• Report Number: 2134265-2015-08122
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: H7493927320350
• Device Catalogue Number: 39273-2035
• Device Lot Number: 17843768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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