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

Model Number M001552040

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Patient age at time of event: (b)(6) of age or older.(b)(6).(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that catheter withdrawal difficulties occurred.The target lesion was located in the carotid artery.A filterwire ez was placed and then the physician implanted a 40mm adapt stent in the lesion.During removal of the stent delivery system (sds) there was a resistance.Force was necessary to remove the sds.After several attempts and maneuvers were performed the physician was able to remove the sds with slight force.The filterwire ez was then removed without problems.The procedure was concluded.No patient complications were reported and the patient status is stable.

• Brand Name: ADAPT¿
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5109826
• MDR Text Key: 26985773
• Report Number: 2134265-2015-06724
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: M001552040
• Device Catalogue Number: 55-204
• Device Lot Number: 17555115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• 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