MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

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

Patient Problems Stroke/CVA (1770); Embolism (1829); Reocclusion (1985); Thrombosis (2100)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Study title: a comparative study of percutaneous atherectomy for femoropopliteal arterial occlusive disease yongquan gu, mahmoud malas, lixing qi, lianrui guo, jianming guo, hengxi yu, zhu tong, xixiang gao, jiang zhang, zhonggao wang international angiology 2017 august; 36(4): 340-5 doi: 10.23736/s0392-9590.17.03797-x.

Event Description

This article presented a study analyzing the experiences in 160 consecutive patients with femoropopliteal arterial occlusive disease who were treated with silverhawk directional atherectomy devices in one university medical center in (b)(6) between october 2010 and december 2013.Of the 160 patients treated, 111 (69%) were male.The mean age of patients was 69.2.72 patients had de-novo stenotic lesion, 15 patients had de-novo occlusive lesions, 49 patients had in-stent restenosis and 24 patients had in-stent occlusion.All 160 patients underwent silverhawk atherectomy of femoropopliteal artery.Spider fx embolic protection was used in 31 cases.One patient experienced no efficacy due to in-stent thrombosis which was treated with thrombolysis and pta with poor outcome and so bypass surgery was carried out.Below the knee amputations were carried out as a result of a serious foot wound in one patient and in-stent thrombosis in two other patients.One patient died 6 days after the operation due to pulmonary embolization.One patient suffered cerebral infraction following the procedure.In cases where embolic protection was not used, three patients sustained distal artery embolization resulting in thrombectomy and stenting.Three patients with gangrene had auto-amputations of the gangrene toes.Two cases where in-stent thrombosis was not recognized before surgery, required urgent bypass surgery and toe amputation.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6749548
• MDR Text Key: 81233972
• Report Number: 2183870-2017-00321
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061188
• 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
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• 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): Required Intervention
• Patient Age: 69 YR