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

Model Number H7493927312270

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the right artery.The 82% stenosed, 9mmx2.75mm, eccentric, de novo target lesion was located in the moderately tortuous and severely calcified right coronary artery.The lesion contained >45 and <90 degrees bend.Following pre-dilation was performed with a 2.75x15mm emerge balloon catheter, a 12 x 2.75mm rebel stent was advanced to treat the lesion and resistance was encountered.The device was removed and it was noted that the proximal of the stent was deformed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the right artery.The 82% stenosed, 9mmx2.75mm, eccentric, de novo target lesion was located in the moderately tortuous and severely calcified right coronary artery.The lesion contained greater than 45 and less than 90 degrees bend.Following pre-dilation was performed with a 2.75x15mm emerge balloon catheter, a 12 x 2.75mm rebel stent was advanced to treat the lesion and resistance was encountered.The device was removed and it was noted that the proximal of the stent was deformed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a rebel stented balloon catheter with the stent fully crimped on the folded balloon.The tip, balloon, stent, shaft were microscopically, tactile and visually inspected.Inspection found no damage or irregularities to the device.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7546685
• MDR Text Key: 109364327
• Report Number: 2134265-2018-04582
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: H7493927312270
• Device Catalogue Number: 39273-1227
• Device Lot Number: 19965467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6F JR4; GUIDE WIRE: PT2 MS 185CM
• Patient Age: 51 YR