MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012451-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other devices mentioned are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that during a right coronary artery stenting procedure, a 3.0 x 15 mm xience sierra drug-eluting stent was deployed across the distal stenosis at 16 atmospheres.At that time, there was a disruption of the proximal to mid right coronary artery stenosis and the decision was made to cover this area with a drug-eluting stent.A 3.5 x 28 mm xience sierra was then successfully implanted and post-dilated with a 3.5x20mm nc trek.After post-dilatation, a perforation was noted.At that time, a 3.5 x16 mm graftmaster covered stent (9072241) was implanted across the perforation at 20 atmospheres (above rated burse pressure), resolving the perforation; however, the stent was post-dilated with the 3.5x20mm nc trek and the perforation was noted to continue to leak.Two additional 3.5x19 graftmaster stents (9112841, 9032941) were implanted, one proximal and one distal to the implanted 3.5x16mm graftmaster stent, but the perforation continued to leak.An additional xience sierra 3.5 x 38 mm stent was implanted but the perforation continued to leak.A 2.8x19mm graftmaster stent (8120641) was advanced, but failed to get distal to the last graftmaster stent and the xience sierra.Another 2.8x19mm graftmaster stent (9092641) kinked upon insertion into the patient.A 3.5x19 graftmaster stent (9060541) was advanced, but failed to cross the implanted xience sierra stent.Another 2.8x19mm graftmaster stent (8120641) was advanced but failed to get distal to the last graftmaster stent and the xience sierra.The patient was taken to surgery where the perforation was treated successfully.There was no reported adverse patient sequela.There was no additional information provided.
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record could not be conducted because the lot number was not provided.The reported patient effect of perforation is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) as known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, surgical procedure, additional treatment and hospitalization appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10759282
• Report Number: 2024168-2020-09051
• Device Sequence Number: 17067428
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• 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): 11/19/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE XPEDITION 3.5X28MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 99