MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number	1011343-30
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.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 similar incidents reported from this lot.The investigation determined that the reported failure to advance appears to be related to circumstances of the procedure.Based on the reported information, anatomical conditions contributed to the difficulty advancing the device through the lesion, which was described as long calcified lesion.Additionally, the treatments also appear to be related to the operational circumstances of the procedure as a surgical cut down was performed to remove the prolapsed sheath, the acculink sds and the filter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The emboshield device is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a long calcified lesion in the right internal carotid artery.Following the difficult placement of a non- abbott introducer sheath, the filter of a large emboshield nav6 embolic protection system (eps) was advanced and successfully deployed distal to the lesion.A 6-8 mm acculink stent delivery system (sds) was advanced but failed to cross the lesion due to the anatomy.The lesion was therefore further pre-dilated with a non-abbott balloon catheter.Whilst the balloon was inflated, the patient suffered a transient ischemic attack and an episode of hypotension.The symptoms were transient while the balloon was inflated.Following this the acculink sds was re-advanced; however did not cross the lesion again due to the anatomy.As a result of the type 2 anatomy, the non-abbott guide sheath prolapsed back and was no longer in the carotid artery.No attempts were made to remove the acculink sds or the filter due to the prolapsed sheath.The patient underwent a surgical cut down to remove the prolapsed sheath, the acculink sds and the filter.A carotid endarterectomy was performed for the lesion.Post procedure the patient was reported to have some slurred speech but was recovering well.No additional information was provided.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8112064
• Report Number: 2024168-2018-09110
• Device Sequence Number: 1694040
• Product Code: NIM
• UDI-Device Identifier: 08717648076367
• UDI-Public: 08717648076367
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: 04/30/2019
• Device Catalogue Number: 1011343-30
• Device Lot Number: 7051861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/28/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR