MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 1012535-100

Device Problems Entrapment of Device (1212); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.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 other incidents.The investigation determined that the reported deployment difficulties were due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified right external iliac artery.A 7x100mm absolute pro was advanced to the lesion, when deploying and having reached partial 20% deployment it was noted that the stent implant got caught on calcification of the vessel and became stuck.The partially deployed implant and deployment system were successfully surgically extracted.The patient remained in the hospital for observation.There was no additional patient sequela.No additional information was reported.

• Brand Name: ABSOLUTE PRO VASCULAR
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10121156
• MDR Text Key: 194101612
• Report Number: 2024168-2020-04766
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176098
• UDI-Public: 08717648176098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 0010761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 58