MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

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

Patient Problems High Blood Pressure/ Hypertension (1908); Tricuspid Regurgitation (2112); Heart Failure (2206); Atrial Perforation (2511)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for atrial septal defect resulting in increased heart failure.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.Two clips were implanted and the mr was reduced to grade 2+.On (b)(6) 2018, the patient was re-hospitalized.The right to left atrial shunt was increased, resulting in increased heart failure and pulmonary hypertension.The mr remained unchanged.Moderate tricuspid regurgitation was noted.Medication was administered.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of hypertension, heart failure, cardiac perforation (atrial perforation) as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on this information, the reported patient effect of atrial perforation appears to be related due to procedural circumstances.Reported patient effects of hypertension, heart failure and tricuspid regurgitation appears to be the cascading effects caused due to atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report filed, additional information was received: the right to left shunt was due to the iatrogenic atrial septal defect (asd) from the mitraclip procedure.Moderate tricuspid regurgitation was related to the asd.The mitraclips were noted to be well attached to both leaflets.No intervention was performed to seal the asd.Medication was administered to treat the heart failure and hypertension.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7911003
• MDR Text Key: 121775780
• Report Number: 2024168-2018-07418
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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 Expiration Date: 02/05/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80205U124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Treatment: IMPLANTED MITRACLIPS (X2)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 39