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 Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Restenosis (4576); Insufficient Information (4580)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Title: effectiveness of combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass: a paradigm shift in surgical open bypass for chronic limb-threatening ischemia author: taira kobayashi, masaki hamamoto, takanobu okazaki journal: vascular year: 2021 vol/issue: vol 29, issue 6 ref: doi: 10.1177/1708538120981224.Age or date of birth: average age.Sex: majority gender.Date of event: date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia.Fifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients.Medtronic¿s in.Pact admiral drug-coated balloon was the first choice, after poba without flow-limiting dissection or recoil.A self-expandable nitinol stent, a stent graft, a drug-eluting stent, or an interwoven nitinol stent were deployed only when flow-limiting dissection or recoil occurred.Technical success of evt was defined as a remaining stenosis of 30%.After confirming the success of femoropopliteal evt, most bypasses were performed in a non-reversed fashion by using a valvulotome.A short bypass was performed in a reversed fashion.Proximal anastomosis and distal anastomosis were performed with a continuous suture by using 6¿0 polypropylene and 7¿0 polypropylene sutures, respectively.After forming an anastomosis, intraoperative completion angiography was routinely performed to evaluate anastomotic configuration and distal runoff.Before closing the wound, the graft flow rate was measured using a transit-time flowmeter.The technical success was 100%.No procedural complications occurred such as wire perforation.One (2%) hospital death occurred because of congestive heart failure.Acute myocardial infarction occurred in one (2%) patient.Surgical site infection occurred in nine (17%) limbs, all of which were treated with conservative treatments.Eighteen (35%) patients required transfusion because of blood loss anemia.No early graft occlusions and early major amputations occurred, and the mean hospital stay was 41 +/- 23 days.The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years, which were not significantly lower compared with those of long bypass originated from femoral artery performed at the same period.The primary patency and freedom from cd-tlr of the sfa evt lesion were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years.The primary patency and freedom from cd-tlr of the sfa evt lesion treated with ¿contemporary device¿ were not significantly higher compared with those of conventional procedure.There was no difference in primary patency and cd-tlr of each ¿contemporary device¿.Cd-tlr of the sfa evt lesion was significantly risk factor for graft occlusion of popliteal-to-distal bypass.Three patients with failed graft required major amputation during the long-term period.The limb salvage rate was 97% at 1 year and 92% at 3 years.Eleven patients died during the follow-up period.The causes of death were cardiac events in six patients, bowel ischemia in one patient, respiratory failure in one patient, stroke in one patient, and unknown cause in two patients.The survival rate was 91% at 1 year and 69% at 3 years.Among 45 limbs with an ulcer or gangrene, complete wound healing was achieved in 35 (76%) limbs.The wound-healing rate was 67% at 6 months and 83% at 12 months.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13150270
• MDR Text Key: 283150401
• Report Number: 9612164-2022-00010
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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: 12/15/2021
• 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: 76 YR
• Patient Sex: Male