MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Migration (4003)

Patient Problems Death (1802); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2020

Event Type  Death  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5092562.

Event Description

Immediately post-replacement of a metallic heart valve, the patient required an emergent thrombectomy procedure in the m1 segment of the left middle cerebral artery (mca).The thrombectomy procedure was performed using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra microcatheter, a non-penumbra sheath, and a non-penumbra stent retriever.It was reported that there was a tight fit between the jet7 and guide catheter.The physician encountered resistance both while advancing and retracting the jet7 through the guide catheter.The physician initially tried to advance the jet7 to the target anatomy without a guidewire or microcatheter unsuccessfully.Then, the physician tried a 035 guidewire but again was unsuccessful reaching target anatomy.Lastly, the physician used a non-penumbra microcatheter and 014 guidewire to successfully reach the target anatomy.A stent retriever was used with jet7 on the first pass using the solumbra technique.After the pass was completed, the microcatheter and stent retriever were removed while the jet7 remained in the internal carotid artery (ica).An angiogram was obtained through the jet7 and showed no recanalization.Although some abnormal contrast leakage was observed, contrast was still emerging from the distal tip; therefore, the physician decided to continue the procedure.The second pass was completed using the solumbra technique with the jet7, microcatheter and stent retriever.Upon removal of all devices except the jet7, part of the clot was caught on the stent retriever.No resistance or other irregularity was noted during this retrieval cycle.The jet7 remained in the ica, and a second angiogram through the jet7 revealed partial recanalization across the prior m1 occlusion followed shortly by a gross extravasation from the supraclinoid segment of the ica.During this same angiogram, the distal tip was seen migrating and becoming lodged within the left supraclinoid segment of the ica, where the vessel had dissected.Upon removal of the jet7, the physician noticed that the distal tip had separated, and some metal braiding was exposed.The thrombectomy was then ended and preventative measures were taken to stop the bleeding.Visualization revealed that the dissected vessel was occluded by both distal and proximal embolization of the vessel; additionally, the m1 had re-occluded.No attempt was made to retrieve the tip.The patient expired the same day due to the vessel dissection.The relationship between the jet7 and vessel dissection is unknown.

Event Description

Immediately post-replacement of a metallic heart valve the patient required an emergent thrombectomy procedure in the m1 segment of the left middle cerebral artery (mca).The thrombectomy procedure was performed using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra microcatheter, a non-penumbra sheath, and a non-penumbra stent retriever.It was reported that there was a tight fit between the jet7 and guide catheter.The physician encountered resistance both while advancing and retracting the jet7 through the guide catheter.The physician initially tried to advance the jet7 to the target anatomy without a guidewire or microcatheter unsuccessfully.Then, the physician tried an 035 guidewire but again was unsuccessful reaching target anatomy.Lastly, the physician used a non-penumbra microcatheter and was only able to get the jet7 to the terminus.Then, the physician even tried deploying the non-penumbra stent retriever as an anchor to try and guide the jet7 to the face of the clot but was unsuccessful and kept the jet7 low in the ica.A stent retriever was used with jet7 on the first pass using the solumbra technique.After the pass was completed, the microcatheter and stent retriever were removed while the jet7 remained in the internal carotid artery (ica).An angiogram was obtained through the jet7 and showed no recanalization.Although some abnormal contrast leakage was observed, contrast was still emerging from the distal tip; therefore, the physician decided to continue the procedure.The second pass was completed using the solumbra technique with the jet7, microcatheter and stent retriever.Upon removal of all devices except the jet7, part of the clot was caught on the stent retriever.No resistance or other irregularity was noted during this retrieval cycle.The jet7 remained in the ica, and a second angiogram through the jet7 revealed partial recanalization across the prior m1 occlusion followed shortly by a gross extravasation from the supraclinoid segment of the ica.During this same angiogram, the distal tip was seen migrating and becoming lodged within the left supraclinoid segment of the ica, where the vessel had dissected.Upon removal of the jet7, the physician noticed that the distal tip had separated, and some coil winds were exposed.The thrombectomy was then ended and preventative measures were taken to stop the bleeding.Visualization revealed that the dissected vessel was occluded by both distal and proximal embolization of the vessel; additionally, the m1 had re-occluded.No attempt was made to retrieve the tip.The patient expired the same day due to the vessel dissection.The relationship between the jet7 and vessel dissection is unknown.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-00170.1.Section b.Box 5.Describe event or problem.H3 other text : placeholder.

Manufacturer Narrative

Potential adverse events with the penumbra system include acute occlusion, death, device malfunction, emboli, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, dissection or perforation, and are included in the labeling.Therefore, it was determined that the reported events were anticipated complications.Results: the jet7 was kinked approximately 20.0 cm from the hub.The jet7 was fractured approximately 129.0 cm from the hub.The distal portion of the fracture jet7 was not returned for evaluation.Conclusions: evaluation of the returned jet7 confirmed a distal fracture.This type of damage typically occurs due to forceful retraction against resistance.Based on the reported event, abnormal contrast leakage was noticed after the first pass.This may indicate the catheter was damaged within the patient prior to fracture.The root cause of this damage could not be determined.Further evaluation of the jet7 revealed a kink.This kink was likely incidental to the complaint.The distal portion of the jet7 was not returned and no other devices identified in the complaint were returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9714918
• MDR Text Key: 179713707
• Report Number: 3005168196-2020-00170
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F92845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 50 YR