MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605); Vascular Dissection (3160); Restenosis (4576); Insufficient Information (4580)

Event Date 11/19/2021

Event Type  Injury  

Event Description

A total of 137 studies were subjected to screening after removal of duplicates.The resultant 49 studies were further screened by full-text assessment to remove publications without full text (n=27), retrospective studies (n=1), and studies without primary outcomes of interest reported (n=2), yielding 19 studies based on 18 unique rcts.Total of 877 and 875 patients in the dcb and pba groups, respectively, were included in the present meta-analysis.These studies were conducted in the united states, (b)(6).Ten studies focused only on patients with avf, study solely included patients with avg,21 and 7 studies enrolled patients with both avf and avg.Patency of dialysis access was evaluated by doppler ultrasounds, fistulogram, and physical examination.Of the 18 studies reviewed in this article 12 reported using medtronic inpact admiral dcb.Target lesion primary patency (tlpp) was reported by 12 studies at 6 months.A total of 493 of 659 (74.8%) and 364 of 682 (53.4%) lesions by dcb and pca were patent, respectively, with an or of 2.93.Based on 10 studies at 12 months, the patency rate in dcb and pca groups were 199 of 416 (47.8%) and 140 of 433 (32.3%), respectively.The or was 2.47.Funnel pl ots suggested possible publication bias at 6 months and 12 months.For patients with avf, the tlpp rates were 338 of 439 (77.0%) versus 258 of 458 (56.3%) at 6 months and 152 of 290 (52.4%) versus 116 of 308 (37.7%) at 12 months for the dcb and pba groups, respectively.Dialysis circuit patency rate at 6 months was reported by 9 studies including 510 and 518 patients treated with dcb and pba, respectively.The rate of circuit patency was 359 of 510 (70.4%) in dcb and 274 of 518 (52.9%) in pba groups.Seven studies reported circuit patency at 12 months.A total of 137 of 318 (43.1%) and 100 of 322 (31.1%) patients had patent dialysis circuits.Funnel plots did not suggest publication bias at 6 months and p=0.535 at 12 months).For the avf subgroup, the circuit patency rates were 288 of 428 (67.3%) versus 228 of 435 (52.4%) at 6 months and 111 of 259 (42.9%) versus 90 of 264 (34.1%) at 12 months for dcb and pba groups, respectively.Based on 9 studies, the tlr rate was 109 of 410 (26.6%) in patients with dcb and 175 of 395 (44.3%) in patients with pba at 6 months.Based on 8 studies at 12 months, the dcb group had a tlr rate of 138 of 248 (55.6%), while pba had a tlr rateof 152 of 245 (62.0%).Funnel plot showed symmetrical distribution.Based on sensitivity analysis, the lack of statistical significance at 12-month follow-up seemed to be the sequela of including the study by bjorkman et al, which draws contradictory conclusions compared with all other studies.The removal of this outlier restored the overall statistical significance, demonstrating a lower tlr rate among patients treated with dcb.In addition to the decrease in heterogeneity from 67.1% to 0.1%, the p value of heterogeneity also increased from 0.003 to 0.64.For patients with avf, the tlr rate was 86 of 352 (24.4%) versus 133 of 339 (39.2%) at 6 months and 94 of 191 (49.2%) versus 100 of 189 (52.9%) at 12 months for the dcb and pba groups, respectively.After the study by bjorkman et al was removed, the tlr rate became 73 of 334 versus 128 of 321 at 6 months and 78 of 173 (42.5%) versus 96 of 171 (55.2%).Mortality was reported by 7 studies at 6 months and 12 studies at 1 year.At 6 months, the mortality rates were 17 of 324 (5.2%) and 14 of 309 (4.5%) among patients who underwent dcb and pba, respectively.Based on 12 studies at 12 months, the mortality rates were 38of 563 (6.75%) and 41 of 563 (7.28%) in the dcb and pba groups, respectively.Funnel plots suggested low risk of publication bias.Among patients with avf, the mortality rates were 12 of 254 (4.7%) versus 10 of 239 (4.2%) at 6 months and 23 of 327 (7.0%) versus 26 of 318 (8.2%) at 12 months for the dcb and pba cohorts, respectively.Six studies reported procedure-related adverse effects.The cumulative incidence of complication was 2.30% in dcb versus 4.35% in pba.The incidence of each category of complication was <(><<)>0.8%, except for the hematoma rate in pba (2%).The following complications were pooled: vasospasm (0.77% versus 0.51%), hematoma (0.26% versus 2.05%), dissection (0.51% versus 0.77%), vein break (0.26% versus 0.77%), pseudoaneurysm (0.26% versus 0%), drug allergy (0.26% versus 0%), and thrombosis arterial embolism (0% versus 0.26%) between dcb and pba, respectively.The drug allergy that occurred in 1 patient with dcb was caused by an allergic reaction to the contrast agent rather than paclitaxel, which subsequently induced athrombosis event that occluded the cephalic vein.Few studies have reported outcomes beyond a 1-year follow-up.Tlpp was analyzed by 3 studies at 18-month (dcb versus pba: 43 of 146 [29.5%] versus 42 of 166 [25.3%], p=0.496) and 2 studies at 24-month follow-up (9 of 104 [8.7%] versus 10 of 119 [8.4%], respectively.Based on the 3 studies at 18-month follow-up, 55 of 56 (98.2%) and 54 of 56 (96.4%) patients with dcb and pba required tlr at 18 months, while 36 of 36 (100%) and 37 of 38 (97.4%) underwent tlr at 24-month follow-up.Two studies reported circuit patency rates at 18-month follow-up with a pooled rate of 24 of 133 (18.0%) and 25 of 150 (16.7%) for the dcb and pba groups, respectively.According to 1 study, no patient maintained circuit patency at 24-month follow- up in either group.Based on 2 studies, the 2-year mortality rates of dcb and pba groups were 46 of 198 (23.2%) and 37 of 200 (18.5%), respectively.

Manufacturer Narrative

Literature title drug-coated balloon versus plain balloon angioplasty for hemodialysis dysfunction: a meta-analysis of randomized controlled trials journal of the american heart association j am heart assoc.2021;10:e022060.Doi: 10.1161/jaha.121.022060.Date of publication.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15025298
• MDR Text Key: 295954889
• Report Number: 9612164-2022-02669
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

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: 07/12/2022
• Initial Date FDA Received: 07/15/2022
• 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