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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Intimal Dissection (1333); Perforation (2001); Stenosis (2263)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

Study title: optical coherence tomography: guided therapy of in-stent restenosis for peripheral arterial disease michael k.Lichtenberg, jeffrey g.Carr, jaafer a.Golzar the journal od cardiovascular surgery 2017 august; 58(4): 518-27 doi: 10.23736/s0021-9509.17.09946-3.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

This review article presents the rational and clinical evidence for utilizing optical coherence tomography (oct)-guided therapies for the treatment of isr for peripheral arterial disease (pad) using directional atherectomy (da)and drug coated balloon (dcb) devices.Total of 8 studies referenced in this review as per below which meet the inclusion criteria.The talon registry, a database of 601 patients treated with the silverhawk da device, reported (b)(4) target-lesion revascularization (tlr) at 6 months, (b)(4) tlr at 12 months, and primary patency of (b)(4) at 12 months.The definitive le trial evaluated 799 patients treated under angiographic guidance with the silverhawk and turbohawk da systems and reported technical success (reduction in residual stenosis (b)(4)) of (b)(4) with 12-month primary patency of (b)(4) for all lesions and (b)(4) in the cto cohort.Safety endpoint examination reveals (b)(4) dissection and (b)(4) perforation rates.In 2004, zeller et al.Reported the early and 6-month results after atherectomy of femoropopliteal lesions using the silverhawk atherectomy catheter.The 71 femoropopliteal stenosis were grouped for analysis per pathology: 30 ((b)(4)) primary stenosis, 27 ((b)(4)) native vessel restenosis, and 14 ((b)(4)) isr.Acute results following atherectomy and additional therapy were identical for the three groups (mean residual stenosis under (b)(4)).Restenosis rates after 6 months were higher for restenotic ((b)(4)) and isr ((b)(4)) lesions as compared to native lesions ((b)(4)), although the difference was not statistically significant.In 2006 zeller et al.Evaluated the long-term results after directional atherectomy using the silverhawk device in 84 patients (131 lesions) with peripheral occlusive disease at a single center.Subjects were categorized into 3 groups by lesion type; de novo lesions ((b)(4)), native vessel restenosis ((b)(4)), and isr ((b)(4)).None of the procedural data differed significantly between groups.Primary patency, was achieved in (b)(4) at 12 months (p=(b)(4)) of native, restenotic and isr lesions, respectively.The tlr rate at 12 months in native, restenotic and isr lesions was (b)(4), respectively.Trentmann et al.(2010) reported the safety and efficacy results of directional atherectomy with the silverhawk device as first-line treatment for isr of the femoropopliteal artery.In this study, 35 femoropopliteal lesions (33 patients) were primarily treated with directional atherectomy.Treatment success with atherectomy alone was achieved in (b)(4) with additional pta ((b)(4)) success increased to (b)(4).Adjunctive stent implantation was necessary in (b)(4) of the cases.The rate of major complication was (b)(4).Target lesion patency at 3, 6 and 12 months was (b)(4), respectively.Shammas et al.(2012) reported a retrospective analysis from a single center on the safety and outcomes of silverhawk atherectomy in the treatment of isr of the femoropopliteal arteries.A total of (b)(6) consecutive patients were followed for a mean of 331.63 days.Bailout stenting was (b)(4).Acute procedural success ((b)(4) angiographic residual narrowing) occurred in (b)(4) of patients.It is reported that the freedom from tlr at 12 months with in.Pact admiral dcb was reported ranging at (b)(4) at 12 months, with primary patency at 12 months ranging from (b)(4) as described in the in.Pact (b)(6) registry which followed-up on (b)(4) patients treated with in.Pact admiral dcb, the debate-isr study which evaluated (b)(4) all-comers diabetic patients with femoropopliteal isr undergoing treatment with paclitaxel-eluting balloons (in.Pact admiral dcb) a(b)(6) follow of the debate-isr study also reported on a ¿catch up phenomena¿ for the dcb group with no longer significant differences in terms of freedom from tlr between the groups: the rate of tlr at (b)(6) follow-up was (b)(4) in the dcb group vs.(b)(4) in the ba group (p=(b)(4)).It is concluded that the introduction of real-time oct imaging combined with directional atherectomy offers superior procedural precision and optimal plaque removal when treating isr lesions.

• 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: 6766242
• MDR Text Key: 81780579
• Report Number: 2183870-2017-00328
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/07/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/04/2017
• 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): Other