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

Model Number	1012582-16
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is returning for analysis; however, it has not been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The three additional graftmaster stents referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a highly calcified right coronary artery (rca).An atherectomy device and was able to cross the lesion after four attempts.Angiography revealed a perforation in the proximal mid vessel.A 2.5x20mm non-abbott balloon was inflated and a second access was obtained in the left common femoral artery.Due to patient's debility, pre-dilatation was performed with a 3.0x15 non-abbott balloon at 12 atmospheres (atms) at 20 seconds with multiple inflations throughout the proximal mid vessel.A 2.8x16mm graftmaster stent delivery system (sds) was attempted to cross into the rca; however, it failed as the stent became stuck with at the proximal portion of the guide catheter.Delay to treat the perforation was noted due to the failure to cross.Another 2.8x26mm graftmaster sds was attempted to cross through the left in the rca; however, also became stuck with the guide catheter.Delay to treat the perforation was noted due to the failure to cross.A 2.75x38mm non-abbott stent was deployed mid vessel, but perforation was still noted.A 3.0x18mm non-abbott balloon was inflated to 15 atms 20 seconds throughout the length of the stent; however, the perforation was still noted.Therefore, another 3.5x18mm non-abbott balloon was inflated to 15 atms, but perforation was still present.The patient was hemodynamically stable throughout this.A 4.0x26mm graftmaster covered stent was deployed at 15 atms for 20 seconds and the stent was apposed, but not well expanded.A 4.0x18mm non-abbott balloon was used to post-dilate; however, perforation was still present.After attempts to cross a 4.0x16mm graftmaster stent to the proximal edge, the shaft of the stent broke and the balloon ruptured without deploying.This was removed; however, unknown how at this moment.A 4.0x30mm non-abbott balloon was advanced distally, inflated at 15 atms and no dissection, perforation, distal embolization or side branch loss noted.The patient became hypoxic and there was not significant pulse.Cardiopulmonary resuscitation (cpr) was performed for 5 to 10 minutes.Percutaneous coronary intervention in the ostial proximal to mid rca with a 2.75x38mm non-abbott stent and followed by a 4.0x16mm non-abbott stent.Thrombus was noted in the mid vessel and was treated with a non-abbott balloon.An impella cp placement was performed with a.035 supra core wire in the left ventricular cavity.During patient's initial episode at times towards the end the patient was episodically hypotensive and a pericardiocentesis needle was used to puncture the pericardium.Echocardiogram revealed an increase effusion.Pericardiocentesis was performed and a catheter was left in place for a pericardial drain.Patient was stabilized and perforation had sealed.The patient was take to cardiovascular icu in critical state.The patient expired later on the same day.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional, and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported material rupture was not confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and material separation appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported material rupture, as it was unable to be confirmed during return analysis testing.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 health effect - impact code 4641 (unexpected medical intervention) was removed and replaced with 2199 (no consequences or impact to patient); medical device problem code 1069 (break) was removed and replaced with 1562 (material separation).
Event or Problem Description
Subsequently, after the initial report was filed the account confirmed the 4.0x16mm graftmaster separated into two pieces at the shaft and the separated portion was removed.The account confirmed there was no intervention to remove the separated portion it was simply pulled out.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: 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: 15428683
• Report Number: 2024168-2022-09747
• Device Sequence Number: 18069667
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 04/30/2023
• Device Model Number: 1012582-16
• Device Catalogue Number: 1012582-16
• Device Lot Number: 1052541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X38MM RESOLUTE ONYX DRUG ELUTING STENT.; 4.0X26MM GRAFTMASTER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male