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

Catalog Number SGC01ST

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

Patient Problem Atrial Perforation (2511)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2016, the patient experienced bilateral cerebral and left cerebellar acute/subacute infarcts due to pre-existing, chronic, right internal carotid artery occlusion and severe focal stenosis of the paraclinoid left internal carotid artery (ica) and left carotid artery occlusion.Following imaging, the patient became hypotensive, unresponsive, and went into respiratory failure.Code blue was called.The patient was intubated, stabilized, and angioplasty of the left ica was performed.Subsequently, worsening of pre-existing anemia and thrombocytopenia occurred and dialysis was initiated for renal failure.Pneumonia occurred and due to worsening condition, the patient was given comfort measures only.On (b)(6) 2016, the patient expired due to respiratory failure, secondary to the stroke.Per study physician, the death, stroke, renal failure, respiratory failure, hypotension, pneumonia, anemia, thrombocytopenia, were all unrelated to any mitraclip device.Additionally per physician, there were no adverse patient effects due to the asd.There was no additional information provided.The customer reported the steerable guide catheter is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The second clip delivery system is filed under a separate medwatch report number.

Event Description

This report is filed on the steerable guide catheter, due to enlargement of the iatrogenic atrial septal defect.It was reported that a mitraclip procedure was performed to treat severe functional mitral regurgitation, grade 4+.The patient presented with a small left atrium.One mitraclip was implanted without issue.A second mitraclip was attempted medial to the first clip.There was difficulty positioning this clip due to visualization and anatomy.During positioning, the clip became stuck in the chordae.The clip was implanted on the chordae in order to remove the delivery system.Per physician, it had taken extra time to visualize the clip for orientation due to visualization difficulty; however, there was no clinically significant delay.Enlargement of the iatrogenic atrial septal defect (asd) was detected, with a rightward bowing of the posterior atrial septum, possible dissection of the interatrial septum with a left to right shunt.No treatment was provided.The procedure was aborted.Post-procedure, mr remained grade 4+ and the procedure was deemed unsuccessful.

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.The reported patient effect of atrial perforation (atrial septal defect), as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of atrial septal defect (atrial perforation) appears to be related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6089631
• MDR Text Key: 59500311
• Report Number: 2024168-2016-07775
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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: 05/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10518U128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: MITRACLIP CLIP DELIVERY SYSTEM (X2)
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 68