MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT®; STENT, CAROTID

Model Number	M001719050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left carotid artery.A 10x31,5.9f,135cm carotid wallstent® stent was advanced to treat the lesion.When the distal embolic protection was pulled through the stenosis, the physician tried to pull the device off of the wire; however, the catheter broke approximately 6-8cm prior to the stent and the stent was left on the wire un-deployed.The catheter that was detached came out over the wire.The guide wire was pulled out with the distal protection device and the device was completely removed from the patient.The procedure was completed with another 10x31mm carotid stent with the used of non-bsc wire.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: an examination of the returned device found a break in the distal outer 210mm distal from middle outer.An examination of the break site found that the outer was stretched at the site of the break.This type of damage is consistent with excessive force being applied to the delivery system during the procedure.The distal end of the device including the stent outer containing the stent was still attached to the ¿distal protection device' retrieval wire.The stent and inner was also noted to be bloody.A visual and tactile inspection identified no issues with the stent or stent holder.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.Bsc id: (b)(4).Tw: (b)(4).
Event or Problem Description
It was further reported that 80% stenosed, target lesion was located in the severely tortuous and severely calcified bovine of aortic arch.

• Brand Name: CAROTID WALLSTENT®
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6637672
• Report Number: 2134265-2017-05823
• Device Sequence Number: 16299714
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: (01)08714729781127(17)20191224(10)0019408576
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/24/2019
• Device Model Number: M001719050
• Device Catalogue Number: 71-905
• Device Lot Number: 0019408576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR