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

Model Number	24700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6)clinical study.It was reported that vessel dissection occurred.In (b)(6) 2018, clinical status assessment identified the subject's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.Target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, with a reference vessel diameter of 6 mm, a length of 7 mm and was classified under unknown tasc ii lesion.Target lesion was treated with pre-dilatation using 6 mm x 80 mm balloon.Following pre-dilatation, the target lesion was treated with standard percutaneous transluminal angioplasty (pta) using 6 mm x 80 mm sterling pta balloon.Post-standard pta treatment, grade 'c' dissection was noted which was treated with bare metal stent bailout.The event was considered resolved.
Event or Problem Description
It was further reported that the dissection was noted during post-dilatation with a 6mmx8mm balloon catheter and not post-standard pta treatment as what previously reported.
Event or Problem Description
Ranger ii sfa clinical study.It was reported that vessel dissection occurred.In (b)(6) 2018, clinical status assessment identified the subject's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.Target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, with a reference vessel diameter of 6mm, a length of 7mm and was classified under unknown tasc ii lesion.Target lesion was treated with pre-dilatation using 6mm x 80mm balloon.Following pre-dilatation, the target lesion was treated with standard percutaneous transluminal angioplasty (pta) using 6mm x 80mm sterling pta balloon.Post-standard pta treatment, grade 'c' dissection was noted which was treated with bare metal stent bailout.The event was considered resolved.It was further reported that the dissection was noted during post-dilatation with a 6mmx8mm balloon catheter and not post-standard pta treatment as what previously reported.It was further reported that the vessel length was 70mm not 7mm as what previously reported.Following balloon angioplasty, angiogram revealed antegrade flow restoration with a recoil stenosis in the mid superficial femoral artery (sfa), which was treated with 6x100mm innova stent.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7837577
• Report Number: 2134265-2018-60564
• Device Sequence Number: 1287408
• Product Code: DQY
• UDI-Device Identifier: 08714729123828
• UDI-Public: 08714729123828
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2019

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: 05/08/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022095220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 10/03/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/01/2018; 10/17/2019
• 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: Required Intervention
• Patient Age: 69 YR