MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Catalog Number RBYPODJ60

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the aortic artery and the inferior mesenteric artery (ima) using pod packing coils (pod j's).During the procedure, the physician successfully deployed and detached six pod j's in the target vessel using a lantern delivery microcatheter (lantern).The physician then retracted the lantern slightly back from within the aortic aneurysm sac to the ima and introduced a seventh pod j.Initially the distal end of the pod j traveled into the aneurysm sac and then started to coil densely into the ima; however, the physician felt the pod j ¿pop¿ and unintentionally detach in the lantern.It was reported that a significant amount of the detached pod j remained in the lantern and the physician used multiple one millimeter syringes to flush the remaining pod j without success.The physician also attempted to push the detached pod j using multiple wires without success.Finally, the physician removed the lantern and proceeded to attempt to snare out the detached pod j which was now distally in the aneurysm sac in the ima and proximally into the aorta.The proximal end of the detached pod j was ultimately snared and while being retracted, broke within the sheath.After multiple other failed attempts to remove it, the remainder of the detached pod j was left in the middle colic artery proximally and distally to the aneurysm sac in the ima.Angiograms were taken which demonstrated that the pod j was not occlusive until in the ima which was the desired result.The patient was to remain in the hospital under a heparin drip for approximately two days and then discharged with close monitoring of symptoms.There was no report of an adverse effect to the patient.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7550761
• MDR Text Key: 109453366
• Report Number: 3005168196-2018-01073
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): N
• Reporter Country Code: TZ
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F82153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• 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; Other; Required Intervention
• Patient Age: 70 YR