MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Necrosis (1971); Renal Failure (2041); Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  Death  

Manufacturer Narrative

As reported in a research article, 100 consecutive patients weighing less than 1000 grams underwent patent ductus arteriosus closure between june 2015 and march 2020; it was reported that one patient implanted with an amplatzer piccolo occluder had signs of signs of necrotizing enterocolitis, renal failure, an aortic arch stenosis secondary to protrusion of the device, respiratory failure, and patient death.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "single-center experience of 100 consecutive percutaneous patent ductus arteriosus closures in infants =1000 grams", was reviewed.This research article is a single center experience to describe the lessons learned from percutaneous patent ductus arteriosus(pda) closures in patients weighing less than or equal to 1000 grams.100 consecutive infants weighing less then 1000 grams underwent transcatheter patent ductus arteriosus(pda) closure between june 2015 to march 2020.The average age was 24.3 days old and the average weight was 821.4 grams.Patient history included: pulmonary hypertension, necrotizing enterocolitis, intraventricular hemorrhage, sepsis and renal impairment.An aortic arch obstructions with the amplatzer piccolo occluder was reported.A (b)(6) infant with multi-organ failure on high frequency ventilator had an amplatzer piccolo occluder successfully implanted completely within the pda (intraductal).However, a week later, with signs of necrotizing enterocolitis (nec) and renal failure, respectively, aortic arch stenosis secondary to protrusion of the device was diagnosed.The patient required stenting of the aorta from a carotid approach.The infant died 14 days post-stenting secondary to respiratory failure.The article concluded that transcatheter pda closure is feasible in infants =1000 g.However, it will find its way into the algorithm for pda management in premature infants only if the procedure is safe.A regimented approach is necessary for success.The primary and correspondence author of the article is ranjit philip, md, 848 adams avenue, memphis, tn 38103 with the corresponding email: rphilip@uthsc.Edu.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12206645
• MDR Text Key: 262861462
• Report Number: 2135147-2021-00286
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 24 DA
• Patient Weight: 1