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

Catalog Number SGC0302

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Shock (2072)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated age.Concomitant medical products: transseptal sheath.Mitraclip ntr clip delivery system.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 to report the femoral vein perforation and hemorrhagic shock.It was reported that this was a mitraclip procedure to treat grade 3-4 functional mitral regurgitation (mr).On (b)(6) 2018, the steerable guide catheter (sgc) was inserted into the mildly tortuous, right femoral vein access site with difficulty.Two or three attempts were made to advance the sgc due to resistance with the femoral vein and the sgc was successfully advanced to the left atrium.The mitraclip ntr clip delivery system was inserted to the mitral valve and one mitraclip ntr was implanted.Post procedure mr grade was reduced to 1; however, the patient became unstable and was found to be in hemorrhagic shock.A perforation was found in the right femoral vein.On (b)(6) 2018 a covered stent was implanted, which successfully stopped the bleeding from the vein.The patient is in stable condition and the hospitalization was prolonged due to the injury.Either the sgc or the transseptal sheath was suspected to have caused the femoral vein perforation.No additional information was provided.

Manufacturer Narrative

Internal file number: (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.Review of the complaint history identified no similar incidents reported from this lot.The reported physical resistance while advancing the sgc (steerable guide catheter) was due to patient anatomy.The reported patient effect of perforation is likely due to the operational context as the physician possibly used extensive force while advancing the sgc or transseptal sheath.The reported hemorrhage and shock were cascading effects of the perforation.The hemorrhage, shock and vessel perforation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

• 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
• MDR Report Key: 8028446
• MDR Text Key: 125792274
• Report Number: 2024168-2018-08345
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

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: 06/29/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80628U123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR