MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCUNET 3-IN-1; EMBOLIC PROTECTION SYSTEM

Catalog Number	1011649-65
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the internal carotid artery.An accunet embolic protection system (eps) was advanced and an unspecified stent was successfully deployed.An attempt to remove the filter of the eps with the retrieval catheters 1 and 2 was made; however, the filter would not collapse into the retrieval catheters.Additional troubleshooting was performed without success.The buddy guide wire technique was used in attempt to facilitate the removal of the filter, but the non-abbott guide wire could not pass through the filter.The guide wire was removed.A non-abbott eps guide wire, an unspecified balloon catheter, and a guideliner were used in attempt to retrieve the filter, but were unsuccessful.At this point, there were concerns the filter was full; therefore, an emboshield nav6 eps retrieval catheter was advanced and was able to retrieve the filter successfully.Outside the patient it was noted that the filter was not full, but one of the struts was broken.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.Visual analysis was performed on the returned device.The reported broken support structure of the filter basket was confirmed.The difficult advancing the guide wire and difficulty removing was unable to be tested due to the condition of the returned product.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 history identified no other incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the filter had a large embolic load preventing the basket from collapsing properly and with continued force, the support structure broke further preventing retrieval.There were no difficulties noted during preparation of the filter basket into the peel-away sheath suggesting that the damage was not pre-existing.The additional therapy/non-surgical treatment was due to case circumstances as an emboshield nav6 eps retrieval catheter was advanced and was able to retrieve the filter successfully.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX ACCUNET 3-IN-1
• Common Device Name: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8876085
• Report Number: 2024168-2019-10688
• Device Sequence Number: 2537194
• Product Code: NTE
• UDI-Device Identifier: 08717648085178
• UDI-Public: 08717648085178
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K081549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 03/31/2021
• Device Catalogue Number: 1011649-65
• Device Lot Number: 9041161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/14/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 84