MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Claudication (2550)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the patient experienced bilateral claudication.In (b)(6) 2018, clinical status assessment indicated the patient's qualifying condition as rutherford category 3.Index procedure was performed on the same day.Target lesion was located in the right sfa had 99% stenosis, with a reference vessel diameter of 5 mm, a length of 140 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation using a 4 mm x 100 mm balloon.Post pre-dilatation, standard percutaneous transluminal angioplasty was performed using 5 mm x 150 mm sterling balloon.With 0% residual stenosis.Also, non-target lesion: left external iliac artery was treated with bare metal stent.The patient was discharged on clopidogrel.In (b)(6) 2018, 159 days post index procedure, during protocol scheduled 6 months follow up, the patient was noted with bilateral claudication.Rutherford class was noted to be 2 (moderate claudication).In (b)(6) 2018, subject presented for scheduled angiography.Angiography without revascularization was performed.At the time of reporting, the event was considered not recovered/ not resolved.
Event or Problem Description
It was reported that the patient experienced bilateral and right lower extremity claudication.In (b)(6) 2018, the patient was presented to the hospital due to rutherford category 3.The patient was referred to cardiac catheterization superficial femoral artery, and index procedure was performed on the same day.The target lesion was located in the right sfa had 99% stenosis, with a reference vessel diameteer of 5mm, a lengthof 140mm and was classified as tasc ii b lesion.The target lesion was treated with pre dilatation using 4 mm x 100 mm balloon.Post pre dilaration, standard pta was performed using 5mm x 150mm sterling balloon.With 0% residual stenosis.A non target lesion left external iliac artery was treated with bare metal stent.The patient was discharged on clopidogrel.It was further reported that in (b)(6) 2018, 159 days post index procedure, during protocol scheduled 6 months follow up, the patient was diagnosed with claudication in the right superficial artery.Rutherford class was noted to be 3 (severe claudication).In (b)(6) 2018, 201 days post index procedure, the 90% mid to distal stenosis in the right sfa was treated with directional atherectomy followed by drug coated balloon angioplasty.On the same day the event was considered recovered and resolved and the patient was discharged on aspirin.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7920631
• Report Number: 2134265-2018-61435
• Device Sequence Number: 1449353
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2019
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0021384564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR