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 Codes	Reocclusion (1985); Vascular Dissection (3160); Restenosis (4576)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that restenosis occurred.In (b)(6) 2018, clinical status assessment identified the patient's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.The target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, reference vessel diameter of 5mm, a length of 100mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation using 4mm x 150mm balloon.Post pre-dilatation, standard percutaneous transluminal angioplasty (pta) was performed with 5mm x 150mm sterling balloon to the target lesion.Following, grade a dissection was noted; however, no action was taken.Post dilatation was also performed.The patient was discharged as an outpatient.In (b)(6) 2018, the patient developed restenosis in the left sfa.No action was taken to treat the event.
Event or Problem Description
Uxa25530 ranger ii sfa study it was reported that restenosis occurred.In (b)(6) 2018, clinical status assessment identified the patient's qualifying condition as rutherford category 3.Subsequently, the index procedure was performed.The target lesion was located in the left superficial femoral artery (sfa) had 100% stenosis, reference vessel diameter of 5mm, a length of 100mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation using 4mm x 150mm balloon.Post pre-dilatation, standard percutaneous transluminal angioplasty (pta) was performed with 5mm x 150mm sterling balloon to the target lesion.Following, grade a dissection was noted however, no action was taken.Post dilatation was also performed.The patient was discharged as an outpatient.In (b)(6) 2018, the patient developed restenosis in the left sfa.No action was taken to treat the event.It was further reported that in (b)(6) 2022, the event was considered as recovered/resolved.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 8232669
• Report Number: 2134265-2018-64891
• Device Sequence Number: 195337
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 09/05/2019
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0021840677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Race: White