MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Catalog Number	PSR3D
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 section of the middle cerebral artery (mca) using penumbra system 3d revascularization devices (psr3ds).It was noted that the patient's anatomy was tortuous.During the procedure, the physician made one unsuccessful attempt in removing the occlusion using a neuron max 6f 088 long sheath (neuron max), penumbra system ace 68 reperfusion catheter (ace68) and a penumbra system 3max reperfusion catheter (3maxc).Therefore, the physician advanced a psr3d through the 3maxc and deployed it in the target vessel to engage and retrieve the thrombus.While retracting the psr3d, no resistance was encountered; however, the psr3d broke off from its pull wire in the patient¿s body.It was reported that the psr3d piece remained in the patient for a few hours before the physician made the decision to remove it.Subsequently, the physician removed and replaced the 3maxc with a velocity delivery microcatheter (velocity) and used a second psr3d to successfully remove the broken psr3d along with the velocity.Next, the physician re-advanced the 3maxc into the ace68 and made multiple attempts of recanalization without success; therefore, the procedure was ended.There was no damage observed to the neuron max, ace68, 3maxc or velocity.Additionally, there was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 sections of the middle cerebral artery (mca) using penumbra system 3d revascularization devices (psr3ds).It was noted that a recombinant tissue plasminogen activator (rtpa) was administered prior to the procedure.Additionally, a computed tomography (ct) scan without contrast and a ct angiography were performed prior to the procedure.During the procedure, the physician made one unsuccessful attempt in removing the occlusion using a penumbra system aspiration pump max (pump max), neuron max 6f 088 long sheath (neuron max), penumbra system ace 68 reperfusion catheter (ace68) and a penumbra system 3max reperfusion catheter (3maxc).Therefore, the physician advanced a psr3d through the 3maxc and deployed it in the target vessel to engage and retrieve the thrombus.While retracting the psr3d, no resistance was encountered; however, the physician noticed in the x-ray preview on the angiograph that the psr3d broke off from its pull wire in the m1/m2.The physician then performed another ct scan and confirmed that the broken psr3d was in the m1/m2 and noticed that the thrombus was not in the broken psr3d.The neuron max, ace68 and 3maxc were then removed and the psr3d piece remained in the patient for approximately two hours, before the physician made the decision to remove it.It was reported that no therapeutic/thrombolytic action was initiated during that time.Subsequently, a clot appeared in the psr3d.The physician then used a new neuron max, ace68, 3maxc and a second psr3d to successfully remove the broken psr3d.Upon removal, a small thrombus was noticed in the psr3ds.The physician then made multiple attempts of recanalization using the second neuron max, ace68, 3maxc and psr3d without success; therefore, the procedure was ended by removing the neuron max, ace68, 3maxc and psr3d.There was no damage observed to either of the neuron maxs, ace68s, or 3maxcs.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 30 september 2019: section b5: describe event or problem.Results: the psr3d stent was fractured off its delivery wire approximately 198.5 cm from the proximal end.Conclusions: evaluation of the returned psr3d confirmed that the stent was fractured off its delivery wire.This type of damage typically occurs if the device is forcefully manipulated against resistance.The reported patient¿s tortuous anatomy may have contributed to the psr3d fracture.The neuron max, ace68, 3maxc, and the psr3d stent were not returned for evaluation.Penumbra psr3ds are visually 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 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8860661
• Report Number: 3005168196-2019-01521
• Device Sequence Number: 13578787
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K162901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2019
• Report Date (Section F): 01/01/2005

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: 12/26/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F87688
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/06/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005