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

Model Number	1012537-100
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 98% stenosed lesion in the left external iliac artery.A 9x100mm absolute pro vascular self-expanding stent system (sess) was implanted without issue.During post-dilatation, while advancing with a 9x80mm armada 35 balloon dilatation catheter (bdc), the physician pushed the edge of the tip of the armada bdc against the implanted absolute pro stent causing resistance between the devices, and the absolute pro sess became stretched.The bdc was removed and replaced with a viatrac 14 plus peripheral balloon dilatation catheter to complete post-dilatation, when the balloon was inflated to 24 atmospheres (atm) and ruptured on the first inflation.The viatrac bdc was removed and the armada bdc was re-inserted to successfully complete the post-dilatation.The stretched absolute sess remains implanted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during post-dilatation while advancing the 9x80mm armada 35 balloon dilatation catheter interaction between the edge of the tip of the armada bdc and the implanted absolute pro stent resulted in resistance between the devices; thus resulting in the reported stretched absolute pro stent and the reported device damaged by another device.There is no indication of a product quality issue with respect to manufacture, design or labeling.The viatrac and armada 35 devices referenced are filed under separate medwatch report numbers.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 15263210
• Report Number: 2024168-2022-08964
• Device Sequence Number: 5566201
• Product Code: NIP
• UDI-Device Identifier: 08717648176258
• UDI-Public: 08717648176258
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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 Expiration Date: 05/31/2025
• Device Model Number: 1012537-100
• Device Catalogue Number: 1012537-100
• Device Lot Number: 2061761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG