MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012817-16

Device Problems Difficult to Insert (1316); Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that after a perforation was noted in the right coronary artery, the 2.8x16mm graftmaster stent system could not be inserted into the guide extension catheter, so the device was advanced without use of the extension catheter.Once at the lesion, negative was pulled and blood was noted in the catheter.It was not identified where the leak was located on the device.The graftmaster stent system was removed without issue.After removal, it was noted that a distal stent strut was flared.There was no adverse patient effect or a clinically significant delay in procedure.Another graftmaster stent was implanted successfully, resolving the perforation.No additional information was provided.

Manufacturer Narrative

A visual, dimensional, and functional inspection was performed on the returned device.The reported material deformation and difficult to insert were not confirmed.The reported leak/splash could not be tested due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties; however, factors which may contribute to difficulty inserting the sds into the guiding catheter include, but are not limited to, manufacturing, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).Factors that could contribute to material deformation include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging of the device, sheath/stylet removal, preparation, during use of the device or interaction with accessory devices.Factors that may contribute to a leak include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.There was no damage noted to the sds during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.Based on the information provided in addition to extensive testing and analysis of the returned device, a conclusive cause for the reported difficulties cannot be confirmed.It is possible that the noted stretched inner/outer member in addition to the noted wrinkled inner/outer member and damaged inner member may have occurred due to inadvertent mishandling during sheath/stylet removal; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13610052
• MDR Text Key: 286240356
• Report Number: 2024168-2022-02049
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 1012817-16
• Device Lot Number: 1072741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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
• Treatment: HIKYAKU GUIDE EXTENSION CATHETER; PROFIT 6FR JR4SH; SION BLUE GUIDE WIRE
• Patient Outcome(s): Other