MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939031602210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Occlusion (1984)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(4) clinical study.It was reported that dissection and restenosis occurred.In (b)(6) 2017, clinical status assessment identified the patient¿s qualifying condition as rutherford category 2.The index procedure was performed on the same day.The target lesion was located in the left superficial femoral artery had 99% stenosis, reference vessel diameter of 4.76 mm, a length of 180 mm, and was classified as a tasc ii c lesion.The lesion was treated with pre-dilatation using 5 mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with a 6.0mmx220mmx150cm (4f) sterling¿ balloon catheter to treat the target lesion.Post deployment of sterling¿ pta balloon, dissection b was noted and no action was taken for the same.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was noted to have left superficial femoral stenosis.No action was taken to treat the event.The event was considered to be not recovered/ not resolved.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2017, the patient presented with symptoms of r-3 intermittent claudication.Vascular ultrasound revealed mid mild to moderate stenosis in the left sfa proximal and slightly accelerated blood flow was noted at the proximal.In (b)(6) 2018, patient was hospitalized for further evaluation and management.The 99% stenosis in left sfa was treated with prestenotic dilatation using a non-bsc, 5 mm x 150 mm balloon followed by long inflation with 6 mm x 150 mm and 6 mm x 120 mm.Non-bsc balloons.Post treatment, 15% stenosis was noted.The following day, the event was considered to be recovered and resolved.The patient was discharged on the same day.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7289957
• MDR Text Key: 100715989
• Report Number: 2134265-2018-01132
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H74939031602210
• Device Catalogue Number: 39031-60221
• Device Lot Number: 20481357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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 Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 79 YR