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

Catalog Number	1003382-18
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending coronary artery.The 5x18mm multilink ultra stent was deployed at 12 atmospheres.The stent balloon faced resistance during removal with the deployed stent despite several attempts.The stent delivery system was removed with force.An unspecified intravascular ultrasound (ivus) catheter was used and confirmed that the stent was not damaged.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficult to remove.It was reported that during retraction, the device met resistance and force was used.It should be noted that the ultra rapid exchange (rx) coronary stent system (css), international, instructions for use, (ifu), specifies: should any resistance be felt at any time during lesion access or delivery system removal, the entire guiding catheter and stent system should be removed as a single unit.It is unknown if the ifu deviation contributed to the reported event.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: ULTRA RX CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9090475
• Report Number: 2024168-2019-11942
• Device Sequence Number: 2592593
• Product Code: MAF
• UDI-Device Identifier: 08717648035319
• UDI-Public: 08717648035319
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1003382-18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1