MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 01/01/2016

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.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, vessel spasm, thrombosis, dissection, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on (b)(6) 2021, penumbra inc.Became aware of a journal article titled, " (b)(6)).This article reports two cases of iatrogenic intracranial dissection out of a cohort of two-hundred and fifty mechanical thrombectomy cases from a single center taking place between (b)(6) 2016 and (b)(6) 2021.In one case, the patient underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68).It was reported that, "when the microcatheter was removed to increase suction force from the penumbra, the penumbra unintentionally shifted up to the mid-m1 which was initially nonoccluded but mildly arteriosclerotic." it was determined that, "based on the appearance of the irregular stenosis and the unintentional shift of the penumbra, this lesion was considered a vessel dissection induced by the tip of the penumbra at an initially atherosclerotic vessel." it was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 11681951
• MDR Text Key: 250033171
• Report Number: 3005168196-2021-00773
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 69 YR