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

Catalog Number	1012534-100
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a mid to distal superficial femoral artery.The vessel was pre-dilatated with 4x80mm armada balloon and the 6.0x100mm absolute pro self-expanding stent was deployed.However, post deployment the stent began to unraveled and part of the stent separated.Another 4.0x60mm armada balloon was used to dilate again and a 6.0x200mm non-abbott stent was used to embedded the separated portion into the vessel wall.A 6.39mm omnilink stent was then implanted in the proximal sfa distal to the profunda origin.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stretched stent and the reported stent material separation were unable to be replicated in a testing environment due to the condition of the returned device (stent not returned).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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after stent deployment during delivery system removal the stent inadvertently got caught on the delivery system and/or the introducer sheath; thus resulting in the reported stretched stent and the reported stent material separation.Manipulation of the compromised device resulted in the noted device damages (multiple sheath wrinkles, jacket smashed/separated, inner member separated).There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 18360447
• Report Number: 2024168-2023-14230
• Device Sequence Number: 7771296
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• 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): 02/29/2024

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: 09/30/2026
• Device Catalogue Number: 1012534-100
• Device Lot Number: 3103061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG