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

Catalog Number 1012534-100

Device Problems Material Separation (1562); Stretched (1601)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event 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.

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
• 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: 18360447
• MDR Text Key: 330931127
• Report Number: 2024168-2023-14230
• Device Sequence Number: 1
• Product Code: NIP
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2023
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 85 KG