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

Catalog Number 1013016-150

Device Problems Break (1069); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

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 performed to treat a lesion in the superficial femoral artery (sfa) with mild calcification, mild tortuosity, and 95% pre-stenosis.An abbott 0.035 gw was used.Pre-dilation of the 5mm vessel was performed with an unspecified 5x200 balloon dilation catheter, inflated to 8 atmospheres for 2 minutes.The 6x150mmx135cm absolute pro stent self expanding stent system (sess) was advanced to the lesion.The thumbwheel was rotated; however, resistance was noted and the stent only partially deployed.The handle was disassembled, and the stent was able to be completely deployed in the intended location.The sess was removed from the anatomy under fluoroscopy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported physical resistance/sticking-thumbwheel and the reported difficult or delayed activation were unable to be replicated in a testing environment due to the condition of the returned device.The reported break was able to be confirmed.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 the device was bent in the mildly calcified, mildly tortuous, and 95% stenosed anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Manipulation of the device resulted in the noted device damages (pinched/wrinkled stent sheath, multiple outer member bends/kinks, multiple jacket stabilizer bends)) likely contributing to the reported difficulties.As reported, the handle was disassembled and the stent was able to be completely deployed in the intended location.During removal of the compromised device interaction with the mildly calcified, mildly tortuous, and 95% stenosed anatomy and/or other devices ultimately resulted in the reported/noted break (separated outer member/hypotube/guidewire lumen).There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

Event Description

Subsequent to the initially filed reports, additional information was provided.It was reported that no resistance was noted during withdrawal of the delivery system; however, after complete withdraw from the anatomy, the hypotube/outer member and guide wire lumen were noted to be separated.But held together by the guide wire lumen material.

• Brand Name: ABSOLUTE PRO LL 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: 18627906
• MDR Text Key: 334367069
• Report Number: 2024168-2024-01332
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013016-150
• Device Lot Number: 3102661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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
• Treatment: 0.035 GUIDE WIRE
• Patient Outcome(s): Required Intervention