MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

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

Patient Problem Restenosis (4576)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

Title: directional atherectomy for treating in-stent restenosis of the superficial femoral artery authors: seung-kee min, ahram han, sang-hyun ahn journal: vascular specialist international year: 2020 vol/issue: 36(3) ref: 0000-0002-1433-2562.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective cross-sectional study among patients with in-stent restenosis (isr) in the superficial femoral artery (sfa).257 limbs in 253 patients underwent stent insertion for superficial femoral artery lesions.Medtr onic¿s complete se stent was used during treatment.73 limbs of 73 patients were excluded due to multiple lesion in index vessels, previous stenting history in index vessels and follow-up loss after the procedure.The clinical record of 180 patients (184 limbs) was reviewed.29 limbs in 27 patients diagnosed as in-stent restenosis.14 limbs underwent atherectomy followed by balloon angioplasty.15 limbs underwent balloon angioplasty alone.Medtronic¿s silverhawk atherectomy device was used for atherectomy.One patient in the atherectomy group, and 4 patient¿s in the balloon angioplasty group were treated with an inpact admiral.Technical success was achieved in all patients in both groups, and procedural success was achieved in 85.7% of the atherectomy group, and 73.3% of the angioplasty group, with no significant differences.Clinical events of residual stenosis (treated by repeated balloon angioplasty), distal embolization (treated by aspiration embolectomy), and flow-limiting dissection (treated by bailout stenting) are reported as outcomes following treatment.At one-year follow-up target lesion revascularization was carried out across the two groups.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11025636
• MDR Text Key: 223611595
• Report Number: 9612164-2020-04952
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110040
• 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: 12/17/2020

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: 12/01/2020
• Initial Date FDA Received: 12/17/2020
• 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: 72 YR