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

Model Number H965SCH647090

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2016

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 foreshortening occurred.The target lesion was located in the carotid artery.A 8.0-36 carotid wallstent(tm) was advanced to treat the lesion.However, during deployment, the length of the stent was found to be shorter than the lesion due to foreshortening.The stent was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the complaint device was returned for analysis.The constrained stent length meets the requirements of the product specification.A visual and tactile examination found no kinks or other damage along the length of the catheter.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 root cause is user preference issue as the product met specification but the user was reportedly dissatisfied with the function, performance or appearance of the product.(b)(4).

Event Description

It was reported that stent foreshortening occurred.The target lesion was located in the carotid artery.A 8.0-36 carotid wallstent was advanced to treat the lesion.However, during deployment, the length of the stent was found to be shorter than the lesion due to foreshortening.The stent was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• 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: 6070077
• MDR Text Key: 58932372
• Report Number: 2134265-2016-09504
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2017
• Device Model Number: H965SCH647090
• Device Catalogue Number: SCH-64709
• Device Lot Number: 0016994146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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
• Patient Age: 88 YR