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

Model Number H749391508290

Device Problems Bent (1059); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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 pain occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified internal carotid artery.After a guidewire crossed the lesion, pre-dilation was performed using a 3.00mm balloon.Then an 8.0-29 carotid wallstent¿ was advanced to treat the lesion but resistance was met from the proximal part of the lesion.The catheter was pushed and pulled several times but the catheter still could not cross the lesion.When the device was removed, it was noted the tip part of the outer sheath was lifted up which caused pain.The device was exchanged and the procedure was completed with another of the same device.No further patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the occurrence of pain did not occur.The previously reported "when the device was removed, it was noted the tip part of the outer sheath was lifted up which caused pain." is corrected to " when the device was removed once, the tip part of the outer sheath seems to be lifted up, so the physician discontinued of using the device".The additional information indicated the previously reported adverse event/serious injury did not occur.

• 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: 6171658
• MDR Text Key: 62311404
• Report Number: 2134265-2016-11593
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Model Number: H749391508290
• Device Catalogue Number: 39150-829
• Device Lot Number: 19342101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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 Outcome(s): Other