MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ADAPT?; STENT, CAROTID

Model Number M001552040

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2013

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that the stent did not deploy.The target lesion was located in a stenosed carotid artery.The 40mm adapt stent was introduced but did not deploy.No patient complications were reported and the procedure as completed with another of the same device.The patient's status is ok.However, device analysis revealed partial stent deployment.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: an inspection of the returned device revealed that the adapt stent delivery system (sds) and stent were received with a guidewire.The guidewire was in the wire lumen protruding 1.2 cm from the tip and 136.5 cm from the guidewire exit notch.A calibrated snap gage was used to measure the outer diameter of the guidewire and was.015¿.There was blood on the devices.The distal end of the stent was partially expanded a length of 27 mm.Functional testing was performed by following device prep and stent deployment steps in the dfu; the stent was deployed with no difficulty.The reported difficulty deploying was not confirmed.There was no evidence of any product quality deficiencies.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause classification of this investigation is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: ADAPT?
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3749315
• MDR Text Key: 4553409
• Report Number: 2134265-2014-02349
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2014
• Device Model Number: M001552040
• Device Catalogue Number: 55-204
• Device Lot Number: 16383926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR