MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number	CDS0201
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint identified no similar incidents reported from this lot.The reported patient effect of failure to retrieve mitraclip system components (foreign body left in patient), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported gripper line break could not be determined.It is possible that the cds experienced compressive forces on the gripper lumens while in the anatomy, constricting the line at a pinch point and resulting in the break; however, this cannot be confirmed.The reported foreign body left in the patient appears to be a result of procedural conditions, as a portion of the line was unable to be retrieved and remained in the patient due to the gripper line break.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
Event or Problem Description
This is filed to report that the gripper line broke and was left in the anatomy.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The clip delivery system (cds) was advanced to the mitral valve.After grasping, the gripper line removability was tested successfully.During gripper line removability, one end was pulled without abnormal resistance until the other end was no longer visible, but the line broke.The cds was removed and the remaining end of the gripper line was pulled from the guide, but the line broke again in the groin.No further attempts were made to remove the remaining portion of gripper line and the patient was given medication to prevent clotting.The patient is currently stable.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6448344
• Report Number: 2024168-2017-02698
• Device Sequence Number: 13600167
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170902(10)60902U239
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60902U239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 79