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

Model Number H965SCH647140

Device Problems Bent (1059); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant city: (b)(6).(b)(4).

Event Description

Same case as mdr id# 2134265-2018-00180.It was reported that stent damage occurred.The target lesion was located in the carotid artery.A 10.0-24mm carotid wallstent¿ was advanced to treat the lesion.However, when the stent was placed in the lesion and re-captured after initial deployment, the distal portion of the deployed stent did not protrude out of the sheath to re-capture.The device was completely removed from the patient.A 10.0-37mm carotid wallstent¿ was advanced through the sheath; however, while passing the guide catheter, the distal portion of the stent was bent and no further progress was made.The entire stent was removed and a 9x4 / 135mm carotid wallstent¿ was used and completed the procedure.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Describe event or problem, device code, device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Age at time of event corrected from (b)(6).(b)(4).Device evaluated by mfr.: the device was received with the stent fully mounted on the delivery system.A significant quantity of dried blood was observed at the distal end of the device.The stent wires at the distal end of the stent were noted to be twisted and had penetrated through the outer sheath of the device prior to investigator attempting to deploy the stent.The investigator was unable to deploy the stent due to the stent wires protruding through the outer.A visual and tactile inspection of the device identified that stent wires had penetrated through the outer sheath of the device.No other issues were noted with the delivery system that could potentially contributed to the complaint incident.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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was further reported that the target lesion was 70% stenosed and was located in the mildly tortuous and non-calcified carotid artery.The distal edge of the 10.0-24mm carotid wallstent¿ was still out of the sheath and was not fully recaptured.

• Brand Name: CAROTID WALLSTENT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7230197
• MDR Text Key: 98875724
• Report Number: 2134265-2018-00181
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: P050019
• 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,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: H965SCH647140
• Device Catalogue Number: SCH-64714
• Device Lot Number: 0021407966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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 Age: 56 YR