MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP PTA BALLOON CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problem Reocclusion (1985)

Event Date 06/26/2016

Event Type  Injury  

Manufacturer Narrative

Date article accepted after revision journal article predictors for better blood-flow restoration of long-segmental below-the-knee chronic total occlusions after endovas cular therapy in diabetic patients copyright © 2016 the korean society of radiology https://doi.Org/10.3348/kjr.2016.17.6.874 pissn 1229-6929 · eissn 2005-8330 original article | intervention.

Event Description

A total of 120 long-segmental (= 5 cm) btk, ctos in 81 patients who underwent recanalization were included in this study.After angioplasty, blood-flow restoration was assessed using modified thrombolysis in myocardial ischemia grades and classified as good flow (grade 3) and poor flow (grade 1/2).One hundred and six ctos with successful recanalization were divided into a good flow group (gfg; n = 68) and poor flow group (pfg; n = 38).Multivariate logistic regression analyses were undertaken to determine independent predictors of blood-flow restoration.Receiver operating characteristic curves were constructed to determine the best cutoff value.The prevalence of target-lesion restenosis during follow-up was compared between two groups.For subintimal recanalization, a steerable guidewire (pt2 or v18; boston scientific, (b)(4)) was used to enter the subintimal space and a catheter (trailblazertm support catheter; ev3, (b)(4); diver, medtronic, (b)(4) or cook, (b)(4)) or a balloon catheter (amphirion deep, medtronic, (b)(4)) was advanced into the subintimal space.A loop was created in the leading portion of the guidewire and advanced distally, until re-entry into the true lumen beyond the occlusion.Total angioplasty was carried out successfully in 91.4% (106/116) of btk ctos (fig.2).The reasons for failure were vessel perforation in 2 ctos, failure of re-entry into the true lumen in 6, and thrombosis in 2.Nine of the 10 failed ctos had poor distal runoff for percutaneous transluminal angioplasty.Bailout btk stent placement was done in 1 case owing to isolated dissection.No procedure-related death occurred.Intraluminal angioplasty was applied in 48 (45.3%) ctos.Abi values showed a significant improvement from 0.40 ± 0.12 before to 0.78 ± 0.15 after recanalization (p <(><<)> 0.001).Altogether, 59 ctos in the gfg and 32 ctos in the pfg underwent duplex sonography or cta/mra follow-up for > 3 months.At the end of follow-up (mean, 10.14 ± 4.13 months), restenosis or re-occlusion occurred in 14 (23.7%) ctos in the gfg and 24 (75%) ctos in the pfg (p <(><<)> 0.01).Kaplan-meier analyses revealed that total patency at 12 months was 60% for patients who underwent successful recanalization of the target lesion.However, further investigation based on restoration of blood flow revealed that lesion patency was much higher in the gfg at 12 months (72.1% vs.43.1% in the pfg; log-rank test p <(><<)> 0.001).During follow-up (mean, 10.67 ± 3.99 months), amputation was undertaken in 1 limb (1.9%) in the gfg and 5 limbs (17.9%) in the pfg (p = 0.02).Kaplan-meier analyses at 12 months revealed the prevalence of total limb salvage as 89.3%, and higher in the gfg (96.0%), as compared with pfg (79.1%; log-rank test, p = 0.02) (fig.3).Pain relief and/or ulcer healing was noted in 92.5% (49/53) and 71.4% (20/28) of patients in the gfg and pfg, respectively (p = 0.02).Re-intervention was required in 7 ctos of 8 limbs in the gfg and 4 ctos of 4 limbs in the pfg, because of symptom recurrence during follow-up.The remaining cases of restenosis or reocclusion were not treated because the patients did not complain of ischemic symptoms.Conclusion: distal runoffs and lesion length are independent predictors for good flow restoration for long-segmental btk, ctos in dm patients who receive endovascular therapy.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapa #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapa #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6292192
• MDR Text Key: 66220551
• Report Number: 9612164-2017-00095
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052791
• 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,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• 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: 01/04/2017
• 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 Age: 71 YR