MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Endocarditis (1834); Fatigue (1849); Pain (1994); Pulmonary Edema (2020); Test Result (2695); Pericardial Effusion (3271)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Implant date: estimated.The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the pericardial effusion.The following was reported through a research article: the mitraclip procedure was performed on (b)(6) 2019.One clip was implanted reducing functional mr to 1+.Three days after the procedure, the patient complained of fatigue, malaise and non-specific epigastric pain.Laboratory results revealed elevated c-reactive protein (crp 70 mg/l) with normal white blood cell count (wbc 9/nl) and normal procalcitonin (pct 0.16 ng/ml).However, chest x-ray detected a bilateral pleural effusion (pulmonary edema).Over the next few days, crp increased further (200 mg/l) while no change of pct was detected.On day five, thransthoracic echocardiogram revealed a circular mild pericardial effusion (8 mm), which progressed to a moderate effusion (13 mm) by day seven.The pericardial effusion remained without hemodynamic relevance.Cardiac computed tomography (ct) confirmed the pericardial and pleural effusion.Cardiac magnetic resonance (cmr) suggested acute pleuro-pericarditis (endocarditis).Anti-inflammatory therapy with high dose aspirin (3g/day) and colchicine (0.5 mg/ day) under gastric protection with a proton pump inhibitor was given.Within days after initiating the therapy, crp decreased, pericardial effusion receded and was no longer detectable after nine days of treatment.The clinical situation of the patient improved.The anti-inflammatory therapy with aspirin was gradually tapered and reduced by 500 mg every 2 weeks.Details are listed in the attached article, titled ¿post-cardiac injury syndrome after transcatheter mitral valve repair using mitraclip system: a case report.¿.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database could not be performed as the lot number and part number are unknown.The reported patient effects of pericardial effusion, pain, endocarditis and pulmonary edema as listed in the mitraclip nt system instructions for use, ce (ifu), are known possible complications associated with mitraclip procedures.Based on the available information, the reported pericardial effusion, fatigue, pain, endocarditis, pulmonary edema and test result were related to a combination of the patient¿s preexisting condition (idiopathic dilated cardiomyopathy with moderately reduced systolic left ventricular function, arterial hypertension, permanent atrial fibrillation, medication including candesartan, carvedilol, torasemide, spironolactone, digoxin, edoxaban) and procedural conditions.The reported treatment with medication and hospitalization were a result of case-specific circumstances as patient was given anti-inflammatory therapy with aspirin and was hospitalized.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10702363
• MDR Text Key: 212281688
• Report Number: 2024168-2020-08718
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

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
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR