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

Catalog Number SGC0302

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: 260cm extra stiff lundequist exchange guide wire, clip delivery system.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the perforation.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The femoral vein was dilated and the steerable guide catheter (sgc) was inserted 10-20 cm; however, resistance was felt with the anatomy.The sgc was removed and the femoral vein was further dilated.The sgc was then advanced successfully.One clip was implanted, reducing mr to 1.When the sgc was removed, the patients blood pressure dropped to 60/30mmhg.An x-ray was used to screen the access site of the femoral vein and a perforation was noted on the proximal section of femoral vein prior to the ivc [inferior vena cava].Medication was given to treat the hypotension and a drug coated balloon was used to treat the perforation and control the bleeding.The blood pressure resolved after 20 minutes of monitoring.The patient was kept hospitalized for monitoring.It is the physician's opinion that the guide wire used to introduce the sgc was not suitable for the tortuous venous anatomy and that the sgc caused or contributed to the perforation.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from the lot.The reported patient effects of vessel perforation and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated, and the difficult to advance (physical resistance) appears to be due to a combination of patient morphology/pathology (tortuous venous anatomy) and user technique/procedural conditions as the guide wire used to introduce the steerable guide catheter (sgc)was not suitable for the tortuous anatomy.The perforation appears to be a result of procedural circumstances of difficult sgc advancement, due to the patient anatomy and guide wire used to introduce the sgc.Hypotension was a cascading effect of the perforation.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: 7869224
• MDR Text Key: 119976342
• Report Number: 2024168-2018-07103
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80524U121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention